AccessGUDID - DEVICE: ATF 120 Fast start kit with AT3 (04052682000843)

GUDID

Device Identifier (DI) Information

Brand Name: ATF 120 Fast start kit with AT3
Version or Model: 9104444
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9104444
Company Name: Fresenius Kabi AG

Primary DI Number: 04052682000843
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315654579 *Terms of Use

Device Description: ATF 120 Fast Start Kit is a kit, consisting of AT3, ATR 120 Autotransfusion reservoir and the ATS Suction Line.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	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.

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.

FDA Product Code

[?]

Product Code	Product Code Name
CAC	Apparatus, Autotransfusion

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 5 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 860d1bd0-1419-4f5c-9960-f1bcf45f3491
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 29, 2016