FDA UDI In Commercial Distribution 🇺🇸 United States

Fenwal Red Cell Freezing Pack 2000 mL

DI: 04052682004254 · Model: 4R2422 · Fresenius Kabi AG
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
Fenwal Red Cell Freezing Pack 2000 mL
Primary DI
04052682004254
Version / Model
4R2422
Catalog Number
4R2422
Company Name
Fresenius Kabi AG
Labeler DUNS
315654579
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-06-23
Public Version
2
Public Version Date
2022-06-17
Public Version Status
Update
Public Device Record Key
2416ff4e-addc-4baf-a001-7bb80ca9be2e

Device Description

Red Cell Freezing Pack 2000 mL

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

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
KSR Container, Empty, For Collection & Processing Of Blood & Blood Components

GMDN Terms

Code Name
44904 Blood/tissue storage/culture container

Identifiers

Type ID
Package 14052682004251
Primary 04052682004254
Previous 00811137010769

Storage Conditions

Type
Special Storage Condition, Specify
Special Conditions
Store at room temperature. Protect from freezing. Avoid excessive heat.