AbbVie Chest Pack

GUDID 38054083008104

The Chest Pack is designed to carry a CADD-Legacy® 1400 pump. This Chest Pack is intended for single-patient use only. The Chest Pack is intended to be put on over the head and fastened around the chest.

ABBVIE INC.

Personal device holder, reusable
Primary Device ID38054083008104
NIH Device Record Key7990281d-7a13-4739-8517-6e3d5cba8b9c
Commercial Distribution StatusIn Commercial Distribution
Brand NameAbbVie Chest Pack
Version Model Number10635
Company DUNS078458370
Company NameABBVIE INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS108054083008103 [Primary]
GS138054083008104 [Package]
Contains: 08054083008103
Package: [10 Units]
In Commercial Distribution

FDA Product Code

IQGAdaptor, Holder, Syringe

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-26
Device Publish Date2021-10-18

Devices Manufactured by ABBVIE INC.

48054083023968 - Skyrizi2022-12-15 The 1.2mL Skyrizi On-Body Injector is designed to be used in conjunction with a pre-filled cartridge assembly containing a 180mg
48054083023234 - Skyrizi2022-07-15 The 2.4mL Skyrizi On-Body Injector is designed to be used in conjunction with a pre-filled cartridge assembly containing a 360mg
38054083008173 - AbbVie Lightweight Vest XS2021-10-27 The Lightweight Vest is designed to carry a CADD-Legacy® 1400 pump. This Lightweight Vest is intended for single-patient use on
38054083008180 - AbbVie Lightweight Vest S2021-10-27 The Lightweight Vest is designed to carry a CADD-Legacy® 1400 pump. This Lightweight Vest is intended for single-patient use on
38054083008197 - AbbVie Lightweight Vest M2021-10-27 The Lightweight Vest is designed to carry a CADD-Legacy® 1400 pump. This Lightweight Vest is intended for single-patient use on
38054083008203 - AbbVie Lightweight Vest L2021-10-27 The Lightweight Vest is designed to carry a CADD-Legacy® 1400 pump. This Lightweight Vest is intended for single-patient use on
38054083008210 - AbbVie Lightweight Vest XL2021-10-27 The Lightweight Vest is designed to carry a CADD-Legacy® 1400 pump. This Lightweight Vest is intended for single-patient use on
38054083008227 - AbbVie Lightweight Vest XXL2021-10-27 The Lightweight Vest is designed to carry a CADD-Legacy® 1400 pump. This Lightweight Vest is intended for single-patient use on

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.