FDA UDI In Commercial Distribution 🇺🇸 United States

AbbVie Chest Pack

DI: 08054083008103 · Model: 10635 · ABBVIE INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
AbbVie Chest Pack
Primary DI
08054083008103
Version / Model
10635
Company Name
ABBVIE INC.
Labeler DUNS
078458370
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-10-18
Public Version
2
Public Version Date
2023-04-04
Public Version Status
Update
Public Device Record Key
7990281d-7a13-4739-8517-6e3d5cba8b9c

Device Description

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.

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
IQG Adaptor, Holder, Syringe

GMDN Terms

Code Name
37685 Personal device holder, reusable

Identifiers

Type ID
Package 38054083008104
Primary 08054083008103