DEVICE: Adult Custom Pack (00607567202993)

Device Identifier (DI) Information

Adult Custom Pack
BEQ-TOP- 32100
Not in Commercial Distribution
701054438
DATASCOPE CORP.
00607567202993
GS1
December 05, 2018
1
001660786 *Terms of Use
701053325 BEQ-HMOD 70000-USA Adult Quadrox iD 701020489 BEQ-RF32 RotaFlow 701045763 Gas Filter
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Device Characteristics

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

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
36347 Cardiopulmonary bypass system roller pump
A mains electricity (AC-powered) device that is a module of a cardiopulmonary bypass system and is used to circulate the blood flow outside of the body for gas exchange and reinfusion via a roller type mechanism. It may be designed with a single or a dual rotor head that presses the blood through the extracorporeal tubing set that is connected to the oxygenator and other parts of the heart-lung bypass system. This pump can also be used to deliver cardioplegia solution at a controlled volume to the patient.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DWE Tubing, Pump, 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

Yes
Yes
Sterilization Method [?]
Ethylene Oxide
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 10 and 30 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

605e27fd-1798-44d3-9dd5-6fd9f64de23c
December 05, 2018
3
October 26, 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
Yes
Yes
No CLOSE

Customer Contact

[?]
18886278383
cpsurgery@maquet.com
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