Device
One+Step INSULIN PEN NEEDLE 32G×5/32" RWLB
Manufacturer
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTD
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTD
Model: 32G×5/32" RWLB
DI: 16958697622214
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-15
Current Version: 2026-05-25
Description
One+Step INSULIN PEN NEEDLE 32G×5/32" RWLB
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
a9ce6a0f-9988-482f-9354-bd651b67755d
Distribution Status:
In Commercial Distribution
DUNS Number:
543007373
Device Count:
100
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:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
26958697622211
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
5000
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
16958697622214
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
16958697622214
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Device ID:
06958697622217
Item #3 - Device ID Type:
Unit of Use
Item #3 - Device ID 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
Premarket Submissions
Submission Number:
K230043
Supplement Number:
000