DEVICE: OCS Lung System (B00939251)
Device Identifier (DI) Information
OCS Lung System
2464
In Commercial Distribution
2464
TRANSMEDICS, INC.
2464
In Commercial Distribution
2464
TRANSMEDICS, INC.
OCS Lung Monitoring Gas Regulator Kit
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
62835 | Donor-organ preservation/transport system gas cylinder regulator |
A reduction valve designed to be attached through a gastight connector (e.g., a pin-index or bull-nosed screw thread connection) to the valve stem of a donor-organ preservation/transport system gas cylinder to lower high, variable gas to a lower, constant working pressure. The regulated gas is typically a custom mix of oxygen, carbon dioxide and nitrogen used for preservation and/or evaluation of the extracorporeal organ.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
QBA | Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Handling Environment Temperature: between -20 and 50 Degrees Celsius |
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure: between 50 and 106 KiloPascal |
Clinically Relevant Size
[?]Size Type Text |
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Height: 3 Inch |
Width: 12 Inch |
Length: 10 Inch |
Device Record Status
3250cb73-c5bc-4ee1-b455-4a17fc7d8a55
July 02, 2018
1
June 01, 2018
July 02, 2018
1
June 01, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
B00939313 | 1 | B00939251 | In Commercial Distribution | Cardboard Box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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
[?]
9785520900
xx@xx.xx
xx@xx.xx