FDA UDI In Commercial Distribution 🇺🇸 United States

AggRecetin

DI: G0561009700 · Model: 1.0-1.5 mg/mL · Bio/Data Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
AggRecetin
Primary DI
G0561009700
Version / Model
1.0-1.5 mg/mL
Catalog Number
100970
Company Name
Bio/Data Corporation
Labeler DUNS
051392959
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-03-23
Public Version
1
Public Version Date
2022-03-31
Public Version Status
New
Public Device Record Key
47957de2-7dc9-4d29-a51d-a17447da1024

Device Description

Ristocetin Sulphate

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
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
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
JOZ System, Automated Platelet Aggregation

GMDN Terms

Code Name
56092 Platelet aggregation study IVD, reagent

Identifiers

Type ID
Primary G0561009700