DEVICE: ROTAFLOW (04037691530864)

Device Identifier (DI) Information

ROTAFLOW
Centrifugal Pump, BIOLINE
In Commercial Distribution
70104.7554
Maquet Cardiopulmonary AG
04037691530864
GS1

1
316153865 *Terms of Use
BEQ-RF-32-USA#RotaFlow Centrifugal Pump with BIOLINE Coating
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Device Characteristics

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

GMDN

[?]

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.
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FDA Product Code

[?]
Product Code Product Code Name
KFM PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
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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
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: connection size 3/8 Inch
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Device Record Status

a12f997c-5851-41e2-b2c4-c5ba2c49c468
March 29, 2018
2
October 30, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
04037691530871 10 04037691530864 In Commercial Distribution
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+49072229320
info.cp@maquet.com
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