AccessGUDID - DEVICE: ROTAFLOW (04037691530864)

GUDID

Device Identifier (DI) Information

Brand Name: ROTAFLOW
Version or Model: Centrifugal Pump, BIOLINE
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 70104.7554
Company Name: Maquet Cardiopulmonary AG

Primary DI Number: 04037691530864
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 316153865 *Terms of Use

Device Description: BEQ-RF-32-USA#RotaFlow Centrifugal Pump with BIOLINE Coating

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

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

GMDN Preferred Term Name	GMDN Definition
Cardiopulmonary bypass system centrifugal pump	A sterile device intended to be connected to a drive unit (not included) to circulate blood through the extracorporeal circuit of a non-roller type cardiopulmonary bypass system, via a centrifugal force mechanism, for gas exchange and reinfusion. It includes a spinning rotor and flow channels; the connected drive unit uses magnetism to spin the rotor; it may in addition be used in extracorporeal support systems for ventricular support/circulatory assistance. This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Cardiopulmonary bypass system centrifugal pump

A sterile device intended to be connected to a drive unit (not included) to circulate blood through the extracorporeal circuit of a non-roller type cardiopulmonary bypass system, via a centrifugal force mechanism, for gas exchange and reinfusion. It includes a spinning rotor and flow channels; the connected drive unit uses magnetism to spin the rotor; it may in addition be used in extracorporeal support systems for ventricular support/circulatory assistance. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
KFM	PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K080470	000

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

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Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
Device Size Text, specify: connection size 3/8 Inch

Device Record Status

Public Device Record Key: a12f997c-5851-41e2-b2c4-c5ba2c49c468
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 30, 2015