Model: Avoset Infusion Pump
Catalog: AAA-00171
DI: 08500835120017
Status: Update
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-02-24
Current Version: 2026-05-11
Description
Avoset Optum Homecare Infusion
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
2
Record Key:
216a7651-1b3f-4e42-804e-1ef74ae36fcb
Distribution Status:
In Commercial Distribution
DUNS Number:
063603014
Device Count:
1
DM Exempt:
Yes
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
08500835120017
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 13215
Name: Bedside infusion pump, single-channel
Definition:
An electrically-powered, non-ambulatory (bedside) device designed to facilitate the accurate and consistent administration of a single drug/solution which can be delivered via intravenous, subcutaneous, arterial, epidural, and intracavital routes using a dedicated infusion set; it is not dedicated to a specific treatment type. It is used to supply higher pressures than those provided by gravity infusion sets or infusion controllers (e.g., typical flow range of 1 to 999 ml/hour) and delivers solutions from a standard infusion bag or bottle of fluid. It is intended primarily for use at the bedside but typically has internal batteries that enable operation, e.g., during transportation.
FDA Product Codes
FRN
Pump, infusion