AccessGUDID - DEVICE: Abbvie Fitted Vest XXXS (08054083022413)

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Device Identifier (DI) Information

Brand Name: Abbvie Fitted Vest XXXS
Version or Model: 0AV551
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ABBVIE INC.

Primary DI Number: 08054083022413
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078458370 *Terms of Use

Device Description: The Fitted Vest is designed to carry a CADD-Legacy® 1400 pump. The Fitted Vest is intended to be an undergarment layer that holds the pump close to the body. The Fitted Vest features a central zipper that rises fully up the torso

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Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
37685	Personal device holder, reusable	A portable device designed to be worn or carried by a patient/layperson to hold a portable medical device (e.g., long-term recorder, wireless antenna, portable oxygen equipment, urine collection bag, tracheostoma protector, infusion pump) during ambulation or sleep; it is neither designed to hold an invasive tube/catheter to the skin surface (i.e., not a catheter/tube holder), nor to house and protect a device from damage (i.e., not a rigid case/housing). It is typically designed as a wearable bag, pouch, strap, belt, headband, or clothing, or as a trolley with wheels. This is a reusable device.	Active	false

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FDA Product Code

Product Code	Product Code Name
IQG	Adaptor, Holder, Syringe

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FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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Storage and Handling

Storage and Handling
No storage/handling found

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Clinically Relevant Size

Size Type Text
No Device Sizes

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Device Record Status

Public Device Record Key: 21d9086b-d68f-4c60-bd72-8075a01a2e56
Public Version Date: September 19, 2024
Public Version Number: 3
DI Record Publish Date: September 20, 2021

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Alternative and Additional Identifiers Additional Identifiers

Package DI

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
38054083022414	15	08054083022413		In Commercial Distribution

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Secondary DI

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

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Unit of Use DI

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
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Production Identifier(s) in UDI

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

No Customer Contact currently defined

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