DEVICE: Cannula Graft™ (05037881009537)

Device Identifier (DI) Information

Cannula Graft™
CGS2008S
In Commercial Distribution
CGS2008S
VASCUTEK LTD
05037881009537
GS1

1
229053087 *Terms of Use
Cannula Graft PVC Cannula with Gelatin Sealed ePTFE Vascular Prosthesis
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
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
Cardiopulmonary bypass cannula, arterial A sterile, semi-rigid or rigid tube intended to be used during open heart surgery where it is surgically inserted for perfusion of the ascending aorta, serving as a channel for the transport of pumped, oxygenated, blood from a cardiopulmonary bypass system (heart-lung machine) tubing circuit. It is typically a moulded plastic tube with stainless steel wire reinforcement, to prevent kinking/collapse, having multiple perforations or flutes at the distal end which help diffuse and disperse incoming blood. It may be inserted using a compatible trocar. Some types may be heparin coated and include a pressure monitoring port. This is a single-use device.
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FDA Product Code

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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 [?]
K081560 000
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: Store in a clean dry area.
Handling Environment Temperature: between 0 and 35 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Lumen/Inner Diameter: 8 Millimeter
Device Size Text, specify: Graft Length 20cm
Length: 50 Centimeter
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Device Record Status

53deba1a-0629-472d-aafd-178f8ffda085
July 06, 2018
3
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
No Package DIs found
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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
Yes
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)262-3304
xx@xx.xx
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