DEVICE: Atellica CH Amm (00630414595832)
Device Identifier (DI) Information
Atellica CH Amm
11097529
In Commercial Distribution
11097529
Siemens Healthcare Diagnostics Inc.
11097529
In Commercial Distribution
11097529
Siemens Healthcare Diagnostics Inc.
Ammonia (Amm) Atellica CH – RGT 480T
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? |
---|---|---|---|---|
53205 | Ammonia IVD, kit, spectrophotometry |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of ammonia in a clinical specimen, using a spectrophotometry method.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JIF | ENZYMATIC METHOD, AMMONIA |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K123320 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
1d5bc684-c728-462e-9f78-b186f070f3a4
April 26, 2024
3
September 24, 2020
April 26, 2024
3
September 24, 2020
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 |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00630414006888
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(877)229-3711
CONTACT@SIEMENS-HEALTHINEERS.COM
CONTACT@SIEMENS-HEALTHINEERS.COM