FDA UDI In Commercial Distribution 🇺🇸 United States

ATR CAP SET

DI: 04052682000751 · Model: 9108574 · Fresenius Kabi AG
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
ATR CAP SET
Primary DI
04052682000751
Version / Model
9108574
Catalog Number
9108574
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
cfce4441-85c0-4f63-9934-0ca2ce5f7186

Device Description

ATR Cap Set is a reserve cap set for the ATR 40 or ATR 120 Autotransfusion reservoir.

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
DTN Reservoir, Blood, Cardiopulmonary Bypass

GMDN Terms

Code Name
17605 Autotransfusion system blood component processing set

Identifiers

Type ID
Package 04052682000775
Package 04052682000768
Primary 04052682000751

Customer Contacts

Phone
+31591355864

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
5 – 30 Degrees Celsius