DEVICE: THORATEC® HEARTMATE II®, SEALED OUTFLOW GRAFT WITH BEND RELIEF (00813024010807)
Device Identifier (DI) Information
THORATEC® HEARTMATE II®, SEALED OUTFLOW GRAFT WITH BEND RELIEF
103393
In Commercial Distribution
103393
Thoratec Corporation
103393
In Commercial Distribution
103393
Thoratec Corporation
No description.
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? |
---|---|---|---|---|
61747 | Implantable ventricular circulatory assist system outflow cannula, animal-derived |
An implantable tube which includes animal-derived materials (e.g., synthetic polymer sealed with mammalian gelatin), intended to function as an outflow for an implantable ventricular circulatory assist system, to channel blood pumped from the left ventricle into the aorta via a surgically-created anastomosis.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DSQ | Ventricular (Assisst) 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 Temperature: between 0 and 35 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
3e80e981-6e35-4c83-ab18-88aebba26b70
February 05, 2021
6
September 20, 2014
February 05, 2021
6
September 20, 2014
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
[?]
+1(855)478-5833
customerservice@sjm.com
customerservice@sjm.com