Model: 194346711994
DI: 00194346711994
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: Yes
First Published: 2026-05-20
Current Version: 2026-05-28
Description
100 Insulin Pen Needles
4mm x 32 Gauge (5/32" x 0.23mm)
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
d4e31881-826a-49f4-aaa0-3b9a4f5ee6cd
Distribution Status:
In Commercial Distribution
DUNS Number:
051957769
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
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:
Yes
Identifiers
Device ID:
00194346711994
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 44127
Name: Autoinjector needle
Definition:
A device designed for the parenteral administration of a drug contained in a cartridge that forms part of, is attached to, or inserted into an autoinjector (drug pen injector). It is used by persons requiring regular, self-administrated dosages of insulin, hormones, or other pharmaceuticals. This device will typically be constructed as a double-ended, stainless steel needle of various sizes that is fixed to a threaded hub of plastic to which the drug pen injector is connected. This device is packaged in a sealed sterility barrier, and might include needle shielding safety features to reduce the risk of needle stick injury. This is a single-use device.
FDA Product Codes
FMI
Needle, Hypodermic, Single Lumen