DEVICE: TandemHeart (00814112020111)
Device Identifier (DI) Information
TandemHeart
5130-1715
In Commercial Distribution
5130-1715
CARDIACASSIST, INC.
5130-1715
In Commercial Distribution
5130-1715
CARDIACASSIST, INC.
15 Fr x 17 cm femoral arterial cannula with 10 Fr introducer
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? |
---|---|---|---|---|
47733 | Cardiopulmonary bypass cannula, femoral |
A sterile, rigid or semi-rigid tube designed to be inserted into a femoral artery or vein during cardiopulmonary bypass procedures. It is typically a 9 to 24 Fr tube with an end hole (some may include side holes); it is short enough to keep the distal tip inside the femoral vessel. The tube is used in set-ups/systems intended to divert the patient's blood to and from external tubing and an arterial pump, bypassing the heart and lungs completely. This is a single-use device.
|
Obsolete | false |
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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Humidity: between 15 and 75 Percent (%) Relative Humidity |
Storage Environment Temperature: between 0 and 40 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
ed3e5d20-9f72-4a03-ba90-e721977f2c27
July 15, 2024
7
October 10, 2015
July 15, 2024
7
October 10, 2015
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
14129637770
xxx@xx.xx
xxx@xx.xx