DEVICE: NA (04037691873077)

Device Identifier (DI) Information

NA
Holding Clamp; Oxygenator QUADROX-iR
In Commercial Distribution
70106.5923
Maquet Cardiopulmonary AG
04037691873077
GS1

1
316153865 *Terms of Use
Holding Clamp for Oxygenator QUADROX-iR
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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
Desk mount A non-dedicated (general-purpose) manually-operated structure designed to be fixed to a desk or a worktop and onto which another medical device (not included) is intended to be safely affixed or mounted. This device is typically clamped (i.e., removable) or permanently screwed to the desk or a worktop surface.
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FDA Product Code

[?]
Product Code Product Code Name
KFM PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
DTM Filter, blood, cardiopulmonary bypass, arterial line
DTZ OXYGENATOR, CARDIOPULMONARY BYPASS
DTR HEAT-EXCHANGER, CARDIOPULMONARY BYPASS
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FDA Premarket Submission

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

Sterilization

No
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
No Device Sizes
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Device Record Status

e34465f9-f744-44cf-8bce-33a9ea5f40f9
March 29, 2018
2
December 15, 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
No Package DIs found
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Secondary DI

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

[?]
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
No
Yes
No CLOSE

Customer Contact

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