FDA UDI In Commercial Distribution 🇺🇸 United States

BIOBASE

DI: 06971674861973 · Model: R1:64mL×6 R2:48mL×2 · Biobase Biodustry(Shandong)Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Let the assistant research this device

The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

Free to try · every answer cites its records

Basic Information

Brand Name
BIOBASE
Primary DI
06971674861973
Version / Model
R1:64mL×6 R2:48mL×2
Company Name
Biobase Biodustry(Shandong)Co., Ltd.
Labeler DUNS
420046355
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-07-21
Public Version
1
Public Version Date
2023-07-31
Public Version Status
New
Public Device Record Key
57483a21-b3ae-4532-aa91-70c39385e275

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
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
Yes
Has Serial Number
Yes
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
CIT Nadh Oxidation/Nad Reduction, Ast/Sgot

GMDN Terms

Code Name
52955 Total aspartate aminotransferase (AST) IVD, reagent

Identifiers

Type ID
Primary 06971674861973