FDA UDI In Commercial Distribution 🇺🇸 United States

PAP-8E Software CD

DI: G0561071530 · Model: 107153 · Bio/Data Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
PAP-8E Software CD
Primary DI
G0561071530
Version / Model
107153
Catalog Number
107053
Company Name
Bio/Data Corporation
Labeler DUNS
051392959
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-08-30
Public Version
1
Public Version Date
2023-09-07
Public Version Status
New
Public Device Record Key
044b4055-033f-43a6-ab68-34f4648478ef

Device Characteristics

Single Use
No
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
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
JPA System, Multipurpose For In Vitro Coagulation Studies

GMDN Terms

Code Name
56699 Platelet aggregation analyser IVD

Identifiers

Type ID
Primary G0561071530