FDA UDI In Commercial Distribution 🇺🇸 United States

Beckman Coulter® PK® Systems Anti-c (951)

DI: 23661562173147 · Model: 17314 · DIAGAST
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Beckman Coulter® PK® Systems Anti-c (951)
Primary DI
23661562173147
Version / Model
17314
Catalog Number
17314
Company Name
DIAGAST
Labeler DUNS
381527001
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2015-09-04
Public Version
3
Public Version Date
2020-10-21
Public Version Status
Update
Public Device Record Key
b2ed15d8-1e91-4c83-9bee-c3aa95e9aca6

Device Description

Blood Grouping Reagent Anti-c (Monoclonal) formulated for Automated Systems, Beckman Coulter® PK® Systems

Device Characteristics

Single Use
No
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
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

GMDN Terms

Code Name
52547 Anti-C [RH004] red blood cell grouping IVD, antibody

Identifiers

Type ID
Primary 23661562173147

Customer Contacts

Phone
800-447-5852

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
2 – 8 Degrees Celsius