FDA UDI In Commercial Distribution 🇺🇸 United States

Perfect 3

DI: 04719871820308 · Model: GOD21 · BIOTEST MEDICAL CORPORATION
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Perfect 3
Primary DI
04719871820308
Version / Model
GOD21
Company Name
BIOTEST MEDICAL CORPORATION
Labeler DUNS
658447255
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-02-23
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
fe68592a-3956-44b8-938a-7e0088751940

Device Description

Perfect 3 Control Solution-Medium

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
Yes
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
CGA Glucose Oxidase, Glucose
JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

GMDN Terms

Code Name
41819 Glucose IVD, control

Identifiers

Type ID
Primary 04719871820308