FDA UDI In Commercial Distribution 🇺🇸 United States

Reinfusion bag 1000 ml

DI: 04052682000607 · Model: 9005204 · Fresenius Kabi AG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Reinfusion bag 1000 ml
Primary DI
04052682000607
Version / Model
9005204
Catalog Number
9005204
Company Name
Fresenius Kabi AG
Labeler DUNS
315654579
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2015-09-01
Public Version
7
Public Version Date
2023-06-02
Public Version Status
Update
Public Device Record Key
7cf15bf0-acf0-4eb4-a13e-306ab536d5e7

Device Description

Reinfusion bag 1000 ml is a replacement reinfusion bag to be used with the AT1 Autotransfusion Set.

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
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
CAC Apparatus, Autotransfusion

GMDN Terms

Code Name
17605 Autotransfusion system blood component processing set

Identifiers

Type ID
Package 04052682000614
Primary 04052682000607

Customer Contacts

Phone
+31591355864

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
5 – 30 Degrees Celsius