Model: Initial Release
Catalog: K08-03294A
DI: 00884450137758
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-30
Current Version: 2026-05-08
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
2411d0d9-5ba6-4174-a09d-533c2ff7cb40
Distribution Status:
In Commercial Distribution
DUNS Number:
184763290
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:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
20884450137752
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
4
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
10884450137755
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
10884450137755
Item #2 - Pkg Status:
In Commercial Distribution
Item #2 - Pkg Quantity:
15
Item #2 - Device ID Type:
Package
Item #2 - Contains DINumber:
00884450137758
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Device ID:
00884450137758
Item #3 - Device ID Type:
Primary
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 58977
Name: Basic intravenous administration set, noninvasive
Definition:
A collection of noninvasive devices intended to conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system; some types may in addition be intended for enteral feeding applications. It typically includes tubing, connectors, chambers, and clamps; the bag/bottle may be included. It neither includes devices intended for invasive use nor a heat exchanger. This is a single-use device.
FDA Product Codes
OJA
Intravenous extension tubing set