DEVICE: ATR 120 Autotransfusion Reservoir (04052682000508)

Device Identifier (DI) Information

ATR 120 Autotransfusion Reservoir
9108474
In Commercial Distribution
9108474
Fresenius Kabi AG
04052682000508
GS1

1
315654579 *Terms of Use
ATR 120 Reservoir is a 3 Liter collection reservoir, containing a 120 µm filter, designated to collect, defoam, filter and store blood prior to processing.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Blood-processing autotransfusion system set A collection of devices designed to handle blood in the washing procedure performed by a blood-processing autotransfusion unit. The collection typically includes plastic tubing, filters (e.g., bacteria), connectors, and bags (e.g., red blood cell, waste); it may also include a disposable bowl for the processing solution (e.g., saline). The set is used as a disposable component of the autotransfusion system during surgery and/or treatment of trauma to remove waste and improve the safety of autologous reinfused blood (autotransfusion). This is a single-use device.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
DTN Reservoir, Blood, Cardiopulmonary Bypass
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 5 and 30 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

613520f6-c924-4017-a16e-2fbe8000ee90
March 29, 2018
2
September 01, 2015
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
04052682000515 8 04052682000508 In Commercial Distribution
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+4961726866735
sabrina.schiffer@fresenius-kabi.com
CLOSE