DEVICE: OCS Lung System (B00939180)
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Device Identifier (DI) Information
OCS Lung System
2461
In Commercial Distribution
2461
TRANSMEDICS, INC.
2461
In Commercial Distribution
2461
TRANSMEDICS, INC.
OCS Lung Monitoring Gas Cylinder, Refill
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? |
|---|---|---|---|---|
| 62834 | Donor-organ preservation/transport system gas refillable cylinder |
A portable container designed as a refillable cylinder to hold a custom gas mixture for use in a donor-organ (e.g., kidney, lung, liver, heart) preservation/transport system. It is typically made of aluminium and fibre glass; the contained gas is typically a custom mix of oxygen, carbon dioxide, and nitrogen used for preservation and/or evaluation of the extracorporeal organ. This is a reusable device.
|
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 |
|---|
| Height: 4 Inch |
| Width: 4 Inch |
| Length: 18 Inch |
Device Record Status
56603483-8401-41f9-bdfd-3ca35a897cb6
March 10, 2021
2
June 01, 2018
March 10, 2021
2
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 |
|---|---|---|---|---|---|
| B00939183 | 2 | B00939180 | 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