Device
100” (254 cm) Primary Administration Set with Universal Spike Drip Chamber (10 drops/mL), Back Check Valve, Blue Pump Key, Roller Clamp, and Two Needle-Free Injection Sites (One at...
Manufacturer
Hartman Medical Group LLC
Hartman Medical Group LLC
Model: PCA1002
DI: 10850048235189
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-19
Current Version: 2026-05-27
Description
100” (254 cm) Primary Administration Set with Universal Spike Drip Chamber (10 drops/mL), Back Check Valve, Blue Pump Key, Roller Clamp, and Two Needle-Free Injection Sites (One at Distal End)
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
9f129d8b-c5a4-4af0-a359-6e665f05de1c
Distribution Status:
In Commercial Distribution
DUNS Number:
117654675
Device Count:
50
DM Exempt:
No
Premarket Exempt:
No
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:
Yes
Identifiers
Item #1 - Device ID:
00850048235182
Item #1 - Device ID Type:
Unit of Use
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
10850048235189
Item #2 - Device ID Type:
Primary
Item #2 - 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
FPA
Set, Administration, Intravascular
Premarket Submissions
Submission Number:
K150513
Supplement Number:
000