Device
35” Secondary Administration Set,10 Drops/mL, Universal vented Spike, 15um filter drip chamber, Roller clamp, Bag Hanger
Manufacturer
Hartman Medical Group LLC
Hartman Medical Group LLC
Model: GCA3510
DI: 10850048235257
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-20
Current Version: 2026-05-28
Description
35” Secondary Administration Set,10 Drops/mL, Universal vented Spike, 15um filter drip chamber, Roller clamp, Bag Hanger
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
a486eb75-8ee7-480b-a7c5-00b1d50a686b
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:
00850048235250
Item #1 - Device ID Type:
Unit of Use
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
10850048235257
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