Model: XXII, 30G
DI: 00810011730724
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: Yes
First Published: 2026-05-21
Current Version: 2026-05-29
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
46135f88-9ddf-4d8a-afd0-bed6f48f3909
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:
No
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:
10810011730721
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
60
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00810011730724
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00810011730724
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Device ID:
50810011730729
Item #3 - Device ID Type:
Unit of Use
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 61578
Name: Manual blood lancing device, single-use
Definition:
A sterile, hand-held manual instrument intended to be used for controlled skin puncture/cut to obtain a capillary blood specimen, performed by a healthcare provider (e.g., on a neonate) or a patient (e.g., a diabetic), typically at the fingertip or ear lobe. It includes a preloaded lancet tip, and has a manually-powered mechanism (e.g., spring-loaded) which enables the tip to puncture to a predetermined depth and blood subsequently to be squeezed out of the puncture site. This is a single-use device.
FDA Product Codes
FMK
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature