Organization accredited by FDA to operate a system for the issuance of UDIs.

Business number issued by Dun & Bradstreet (D&B) that is used to associate the Labeler (Company) name and address to a given version of model of a device in GUDID.

An unmarked identifier assigned to an individual medical device when a UDI is not labeled on the individual device at the level of its unit of use. Its purpose is to associate the use of a device to/on a patient. The Unit of Use DI does not appear on the label of the device.

The catalog, reference, reorder or product number used by the labeler for business and clinical transactions to identify a particular product; this number may be found on the device label or labeling.

Additional information about the device that is not already captured as a distinct GUDID data element.

Indicates the date the device is no longer held or offered for sale. See 21 CFR 807.3(b) for exceptions. The device may or may not still be available for purchase in the marketplace.

(Device) If no Commercial Distribution End Date is entered, the status is "In Commercial Distribution" - (Package) If Package DI and related elements are entered and no Package Distribution End Date is entered, the status is "In Commercial Distribution."

The device is exempt from Direct Marking requirements under 21CFR 801.45.

An identifier that is permanently marked directly on the medical device. Certain devices are required to be directly marked.  Under 21 CFR 801.45(b), the direct mark DI may be identical to or different from the Primary DI. 

Name of Secondary DI Issuing Entity.

An identifier that is an alternate (secondary) lookup for a medical device that is issued from a different issuing entity than the primary DI.

Under 21 CFR 830.40(a), only one device identifier from any particular system for the issuance of UDIs may be used to identify a particular version or model of a device.

Phone number for the Customer contact; to be used by patients and consumers for device-related questions.

Email for the Customer contact; to be used by patients and consumers for device-related questions.

A device identifier for the package configuration that contains multiple units of the base package (does not include shipping containers).

For example: 4 glove boxes in a Carton -- Package DI =201 (the UDI on the Carton) 5 Cartons in a Case -- Package DI=301 (the UDI on the Case) contains a 5 cartons (with DI 201) with 4 glove boxes in a carton 10 glove boxes in a Carton -- Package DI=202 (the UDI on the Carton).

The number of packages with a unique primary DI within a given packaging configuration. 

For example: Package configuration Carton with Package DI=201 contains 4 boxes of the base package DI=101, the quantity per package is 4; Package configuration Case with Package DI=301 contains 5 cartons of Package DI=201, the quantity per package is 5. Package configuration Carton with Package DI=202 contains 10 boxes of the base package DI=101; the quantity per package is 10.

The Primary DI for the base package or the Package DI for any lower level package configuration contained within a given package configuration.

For example:

• Package DI=002 and Package DI=003 contain the base package Case with primary DI=001;
• Package DI=004 contains lower level package configuration of a Carton with Package DI=003.

Text to describe the outer packaging of the product and enables users to understand higher level packaging configurations.

Indicates the date this particular package configuration is discontinued by the labeler.

(Device) If no Commercial Distribution End Date is entered, the status is "In Commercial Distribution" - (Package) If Package DI and related elements are entered and no Package Distribution End Date is entered, the status is "In Commercial Distribution."

A device identifier for the package configuration that contains multiple units of the base package (does not include shipping containers).

For example: 4 glove boxes in a Carton -- Package DI =201 (the UDI on the Carton) 5 Cartons in a Case -- Package DI=301 (the UDI on the Case) contains a 5 cartons (with DI 201) with 4 glove boxes in a carton 10 glove boxes in a Carton -- Package DI=202 (the UDI on the Carton).

The number of packages with a unique primary DI within a given packaging configuration. 

For example: Package configuration Carton with Package DI=201 contains 4 boxes of the base package DI=101, the quantity per package is 4; Package configuration Case with Package DI=301 contains 5 cartons of Package DI=201, the quantity per package is 5. Package configuration Carton with Package DI=202 contains 10 boxes of the base package DI=101; the quantity per package is 10.

The Primary DI for the base package or the Package DI for any lower level package configuration contained within a given package configuration.

For example:

• Package DI=002 and Package DI=003 contain the base package Case with primary DI=001;
• Package DI=004 contains lower level package configuration of a Carton with Package DI=003.

Text to describe the outer packaging of the product and enables users to understand higher level packaging configurations.

Indicates the date this particular package configuration is discontinued by the labeler.

(Device) If no Commercial Distribution End Date is entered, the status is "In Commercial Distribution" - (Package) If Package DI and related elements are entered and no Package Distribution End Date is entered, the status is "In Commercial Distribution."

A device identifier for the package configuration that contains multiple units of the base package (does not include shipping containers).

For example: 4 glove boxes in a Carton -- Package DI =201 (the UDI on the Carton) 5 Cartons in a Case -- Package DI=301 (the UDI on the Case) contains a 5 cartons (with DI 201) with 4 glove boxes in a carton 10 glove boxes in a Carton -- Package DI=202 (the UDI on the Carton).

The number of packages with a unique primary DI within a given packaging configuration. 

For example: Package configuration Carton with Package DI=201 contains 4 boxes of the base package DI=101, the quantity per package is 4; Package configuration Case with Package DI=301 contains 5 cartons of Package DI=201, the quantity per package is 5. Package configuration Carton with Package DI=202 contains 10 boxes of the base package DI=101; the quantity per package is 10.

The Primary DI for the base package or the Package DI for any lower level package configuration contained within a given package configuration.

For example:

• Package DI=002 and Package DI=003 contain the base package Case with primary DI=001;
• Package DI=004 contains lower level package configuration of a Carton with Package DI=003.

Text to describe the outer packaging of the product and enables users to understand higher level packaging configurations.

Indicates the date this particular package configuration is discontinued by the labeler.

(Device) If no Commercial Distribution End Date is entered, the status is "In Commercial Distribution" - (Package) If Package DI and related elements are entered and no Package Distribution End Date is entered, the status is "In Commercial Distribution."

Indicates that the product contains or consists of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient as defined under 21 CFR 1271.3.

Indicates that the device is a convenience, combination, in vitro diagnostic (IVD), or medical procedure kit. Kits are a collection of products, including medical devices, that are packaged together to achieve a common intended use and is being distributed as a medical device.

Indicates that the product is comprised of two or more regulated products that are physically, chemically, or otherwise combined or mixed and produced as a single entity; packaged together as a single package; or packaged separately for the intended use together as defined under 21 CFR 3.2(e). At least one of the products in the combination product must be a device in this case.

FDA Premarket submission is not required for this device.

The FDA premarket submission number of those products requiring premarket approval or notification before being marketed in the U.S., including medical devices and products with medical device constituents regulated by CDER, CBER and CDRH. Petition number for devices granted marketing authorization via a De Novo petition is also accepted in the FDA Premarket Submission Number field. Submission types included are 510(k), De Novo, PMA, PDP, HDE, BLA, ANDA and NDA.

Number assigned by FDA to a supplemental application for approval of a change in a medical device with an approved PMA, HDE, ANDA, NDA, BLA or PDP.

Number assigned by FDA during Registration and Listing to all devices in commercial distribution, regardless of pre-market authorization requirements per 21 CFR 807.28(f).

Categorization for devices used by the FDA.

Unique numerical five-digit number used to generically identify medical devices and related health care products.

Indicates that the device is intended for one use or on a single patient during a single procedure.

Indicates the device is managed by lot or batch number. This number can be found on the device label or packaging. Lot or Batch means one finished device or more that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits.

Indicates the device is managed by serial number. This number can be found on the device label or packaging. The serial number is assigned by the labeler and should be specific to each device.

Indicates the device is managed by expiration date; the date by which the label of a device states that the device must or should be used.

Indicates the device is managed by date of manufacture; the date a specific device was manufactured.

Indicates the device is managed by a Donation Identification Number. This number can be found on the device label or packaging. The Donation Identification Number is applicable to devices that are also regulated as HCT/Ps and is a number that is assigned to each donation.

Indicates that the device requires a prescription to use.

Indicates that the device does not require a prescription to use and can be purchased over the counter (OTC).

Indicates that the device or packaging contains natural rubber that contacts humans as described under 21 CFR 801.437. Choosing "Yes" indicates that the device label or packaging contains one of the following statements: (1) "Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions", (2) This Product Contains Dry Natural Rubber", (3) Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions" or (4) "The Packaging of This Product Contains Dry Natural Rubber".

Indicates that natural rubber latex was not used as materials in the manufacture of the medical product and container and the device labeling contains this information. Only applicable to devices not subject to the requirements under 21 CFR 801.437. Not all medical products that are NOT made with natural rubber latex will be marked.

Indicates the MRI Safety Information, if any, that is present in the device labeling. Please see the ASTM F2503-13 standard for more information.

Numeric value for the clinically relevant size measurement of the medical device.

The unit of measure associated with each clinically relevant size. The unit of measure must conform to UCUM standards.

Additional undefined device size not represented in the GUDID clinically relevant size list.

Numeric value for the clinically relevant size measurement of the medical device.

The unit of measure associated with each clinically relevant size. The unit of measure must conform to UCUM standards.

Additional undefined device size not represented in the GUDID clinically relevant size list.

Numeric value for the clinically relevant size measurement of the medical device.

The unit of measure associated with each clinically relevant size. The unit of measure must conform to UCUM standards.

Additional undefined device size not represented in the GUDID clinically relevant size list.

Indicates storage and handling requirements that are required for the device including temperature, humidity, and atmospheric pressure.

Indicates the low value for storage and handling requirements.

Indicates the high value for storage and handling requirements.

The unit of measure associated with the storage and handling conditions.

Indicates any special storage requirements for the device.

Indicates storage and handling requirements that are required for the device including temperature, humidity, and atmospheric pressure.

Indicates the low value for storage and handling requirements.

Indicates the high value for storage and handling requirements.

The unit of measure associated with the storage and handling conditions.

Indicates any special storage requirements for the device.

Indicates storage and handling requirements that are required for the device including temperature, humidity, and atmospheric pressure.

Indicates the low value for storage and handling requirements.

Indicates the high value for storage and handling requirements.

The unit of measure associated with the storage and handling conditions.

Indicates any special storage requirements for the device.

Indicates the medical device is free from viable microorganisms. See ISO/TS 11139.

Indicates that the device requires sterilization prior to use.

Indicates the method(s) of sterilization that can be used for this device prior to device use on the patient.

The Entry LOVs represent the sterilization methods recognized by the CDRH Infection Control Branch. Methods selected should be only those approved for each device by the CDRH Office of Device Evaluation.

Indicates the method(s) of sterilization that can be used for this device prior to device use on the patient.

The Entry LOVs represent the sterilization methods recognized by the CDRH Infection Control Branch. Methods selected should be only those approved for each device by the CDRH Office of Device Evaluation.

Indicates the method(s) of sterilization that can be used for this device prior to device use on the patient.

The Entry LOVs represent the sterilization methods recognized by the CDRH Infection Control Branch. Methods selected should be only those approved for each device by the CDRH Office of Device Evaluation.

Number of medical devices in the base package.
For example, Base Package = Box of 100 gloves;
Primary DI = 101;
Device Count = 100.

Value is one of the following:

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