FDA UDI In Commercial Distribution 🇺🇸 United States

AIMSTRIP PLUS BLOOD GLUCOSE METER, BOX KIT

DI: 00695684373214 · Model: 37321 · GERMAINE LABORATORIES, INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
AIMSTRIP PLUS BLOOD GLUCOSE METER, BOX KIT
Primary DI
00695684373214
Version / Model
37321
Company Name
GERMAINE LABORATORIES, INC
Labeler DUNS
176458115
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-04-27
Public Version
3
Public Version Date
2022-09-29
Public Version Status
Update
Public Device Record Key
b5efc267-34b7-48d7-8d95-f6c4aa041e90

Device Description

A blood glucose meter for use with AimStrip® Plus Blood Glucose Test Strips for testing blood glucose levels.

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
NBW System, Test, Blood Glucose, Over The Counter

GMDN Terms

Code Name
60740 Home-use blood glucose spot-check system

Identifiers

Type ID
Primary 00695684373214