FDA UDI In Commercial Distribution 🇺🇸 United States

ATF 40 Fast start kit with AT3

DI: 04052682000805 · Model: 9108444 · Fresenius Kabi AG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
ATF 40 Fast start kit with AT3
Primary DI
04052682000805
Version / Model
9108444
Catalog Number
9108444
Company Name
Fresenius Kabi AG
Labeler DUNS
315654579
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-30
Public Version
7
Public Version Date
2023-06-02
Public Version Status
Update
Public Device Record Key
7082b8e6-071d-4d55-b415-c8db2cee2486

Device Description

ATF 40 Fast Start Kit is a kit, consisting of AT3, ATR 40 Autotransfusion reservoir and the ATS Suction Line.

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
Yes
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 04052682000812
Primary 04052682000805

Customer Contacts

Phone
+31591355864

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
5 – 30 Degrees Celsius