Model: HH-XIII-T
DI: 00810011730700
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: Yes
First Published: 2026-05-11
Current Version: 2026-05-19
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
74606df9-dbc3-4264-9bc5-4a08f5c0be86
Distribution Status:
In Commercial Distribution
DUNS Number:
421272490
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:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
00810011730700
Item #1 - Device ID Type:
Primary
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Pkg Type:
case
Item #2 - Device ID:
10810011730707
Item #2 - Pkg Status:
In Commercial Distribution
Item #2 - Pkg Quantity:
500
Item #2 - Device ID Type:
Package
Item #2 - Contains DINumber:
00810011730700
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 37243
Name: Manual blood lancing device, reusable
Definition:
A hand-held manual instrument intended to be used for controlled skin puncture to obtain a capillary blood specimen (e.g., performed by a diabetic patient) typically at the fingertip or ear lobe. It is used with a sterile, disposable 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 reusable device.
FDA Product Codes
QRL
Multiple Use Blood Lancet For Single Patient Use Only