DEVICE: SMT (05430003710005)
Device Identifier (DI) Information
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| No | |
| No | |
| 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? |
|---|---|---|---|---|
| 58754 | Nitric oxide refillable cylinder |
A container designed as a refillable cylinder used to hold compressed nitric oxide (NO), also known as nitrogen monoxide, under safe conditions at high pressure. It is typically filled with NO when delivered from the gas supplier and includes a valve stem, an opening/closing valve, and will be graded according to size (capacity) and colour-coded to denote NO content. The cylinder is made of non-corrosive aluminium (Al) and must be used with a pressure regulator in order to release the NO at the correct working pressure. NO is used for severe respiratory problems in neonates, children, and adults, e.g., for treatment of primary pulmonary hypertension (PPH) and some surgical interventions.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| ECX | Cylinder, Compressed Gas, And Valve |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
507a35d0-d856-4140-8fc1-fcf5922f98ad
November 28, 2023
1
November 20, 2023
November 28, 2023
1
November 20, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| 05430003710012 | 1 | 05430003710005 | In Commercial Distribution | Cardboard box | |
| 05430003710029 | 4 | 05430003710012 | 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
[?]
No Customer Contact currently defined