DEVICE: NA (04037691122274)

Device Identifier (DI) Information

NA
Art.Can., reinf.,straight, with stylet
Not in Commercial Distribution
70102.2681
Maquet Cardiopulmonary AG
04037691122274
GS1
January 31, 2020
1
316153865 *Terms of Use
Arterial Cannula, wire reinforced, straight tip, stylet, with Luer lock connector
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
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?
34893 Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return
A semi-rigid or rigid tube intended to be surgically inserted into an artery or vein to serve as a channel for the extracorporeal transport of oxygenated blood to a patient during cardiopulmonary bypass and/or extracorporeal membrane oxygenation; in some settings it may be referred to as an arterial cannula. It is typically inserted using a compatible trocar blade which may be included. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DWF CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K023251 000
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
Catheter Gauge: 8 French
Device Size Text, specify: Connector with LL 3/16 Inch
Length: 21.5 Centimeter
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Device Record Status

29c7cfe4-6300-4bc0-93aa-62a5cbaaa67d
June 19, 2024
6
October 24, 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
04037691018065 10 04037691122274 2020-01-31 Not in Commercial Distribution
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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

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