FDA UDI In Commercial Distribution 🇺🇸 United States

DIABETES CNTL, Smpl, 1x2x0.5mL

DI: 00817238010394 · Model: 91819 · CLINIQA CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
DIABETES CNTL, Smpl, 1x2x0.5mL
Primary DI
00817238010394
Version / Model
91819
Company Name
CLINIQA CORPORATION
Labeler DUNS
078742335
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-08-22
Public Version
2
Public Version Date
2019-02-04
Public Version Status
Update
Public Device Record Key
73f0eb33-43f9-492e-92e4-498e040d03f6

Device Description

DIABETES CONTROL SAMPLE PACK

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
Yes
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
JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

GMDN Terms

Code Name
41819 Glucose IVD, control

Identifiers

Type ID
Primary 00817238010394