DEVICE: PEMCO INC (B1521580P053MM750)

Device Identifier (DI) Information

PEMCO INC
1580-P-05-3MM-75
In Commercial Distribution
1580-P-05-3MM-75
PEMCO INC
B1521580P053MM750
HIBCC

1
004217071 *Terms of Use
Perfusion Cannula. Small Handle 6.5 inches long. Style # 5 Swivel Tip with side holes -3 MM Tip Diameter. 75 Degree Bend. Also available in: Large, Flag, & Tube Handle Styles
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
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
Coronary artery cannula, reusable A rigid or semi-rigid tube designed to be surgically inserted, temporarily, into a coronary artery to serve as a channel for the transport of fluid during a surgical intervention. It is typically intended for the infusion and/or perfusion of fluids in diagnostic and/or surgical procedures, such as cardiopulmonary bypass, and to help avoid ischemia. Insertion is typically achieved with the use of a removable stylet or trocar. This is a reusable device intended to be sterilized prior to use.
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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 [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

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

[?]
Size Type Text
Angle: 75 degree
Height: 6.5 Inch
Outer Diameter: 3 Millimeter
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Device Record Status

2a6a7644-e105-40e2-945c-cdf967b92842
March 29, 2018
2
September 26, 2016
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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

[?]
12165242990
info@pemcomed.com
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