AccessGUDID - DEVICE: ATO Oxygenator line (04052682000621)

GUDID

Device Identifier (DI) Information

Brand Name: ATO Oxygenator line
Version or Model: 9108434
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9108434
Company Name: Fresenius Kabi AG

Primary DI Number: 04052682000621
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315654579 *Terms of Use

Device Description: ATO Oxygenator line is a tubing system to connect an oxygenator with one fourth inch male connector to an Autotransfusion device.

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:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
17605	Autotransfusion system blood component processing set	A collection of noninvasive devices that typically includes tubing, containers (e.g., bags or bowls for treatment, reinfusion, waste disposal) and filters intended to be used to process (filter/wash) blood components (e.g., red or white blood cells, platelets) in conjunction with a dedicated pump (not included) as part of an autotransfusion procedure; it is not dedicated to suction and/or anticoagulation. This is a single-use device.	Active	false

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: 9822e2bc-e4d0-4e12-a41b-86ea2bf22b2e
Public Version Date: June 02, 2023
Public Version Number: 7
DI Record Publish Date: September 01, 2015