Device
Start of Care Kit-Subq
Manufacturer
Optum Distribution Center, LLC
Model: MMM-00042 Catalog: MMM-00042 DI: 08500835120079 Status: Update MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: Yes OTC: No
First Published: 2026-04-28 Current Version: 2026-05-11
Description
Start of Care Kit-Subq
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 2
Record Key: bcc0619a-7ddb-4b6e-add7-787271f8141a
Distribution Status: In Commercial Distribution
DUNS Number: 063603014
Device Count: 1
DM Exempt: No
Premarket Exempt: Yes
HCT/P: No
Kit: Yes
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: No
Manufacturing Date Tracked: Yes
Expiration Date Tracked: Yes
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 08500835120079
Type: Primary
Issuing Agency: GS1
GMDN
Code: 35833
Name: Electric infusion pump administration set, single-use
Definition:
A collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device.
FDA Product Codes
OJA
Intravenous extension tubing set
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit: Degrees Fahrenheit
Storage Handling - Storage Handling Low - @attributes - Value: 40
Storage Handling - Storage Handling High - @attributes - Unit: Degrees Fahrenheit
Storage Handling - Storage Handling High - @attributes - Value: 86
Storage Handling - Storage Handling Type: Storage Environment Temperature