Model: IK, 28G
DI: 00810011730687
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: Yes
First Published: 2026-05-06
Current Version: 2026-05-14
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
b12b60a6-3281-4e97-b13e-304cfea94caa
Distribution Status:
In Commercial Distribution
DUNS Number:
421272490
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 - Pkg Type:
Case
Item #1 - Device ID:
10810011730684
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
200
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00810011730687
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00810011730687
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Device ID:
50810011730682
Item #3 - Device ID Type:
Unit of Use
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 45142
Name: Blood lancing device tip
Definition:
A sterile, sharp, needle-like device intended to be loaded into a blood lancing device to function as the invasive portion of the assembly during skin puncture for capillary blood sampling, typically performed at a fingertip or ear lobe (e.g., by diabetic patients). This is a single-use device.
FDA Product Codes
QRL
Multiple Use Blood Lancet For Single Patient Use Only
QRK
Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature