DEVICE: DEXTROMETHORPHAN PLUS (B800UTAKUCDEXSD0)
Device Identifier (DI) Information
DEXTROMETHORPHAN PLUS
UTAK-UC DEX+ SD
In Commercial Distribution
UTAK-UC DEX+ SD
UTAK LABORATORIES, INC.
UTAK-UC DEX+ SD
In Commercial Distribution
UTAK-UC DEX+ SD
UTAK LABORATORIES, INC.
DEXTROMETHORPHAN PLUS
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? |
---|---|---|---|---|
30503 | Multiple therapeutic drugs/drugs of abuse IVD, control |
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of multiple therapeutic drugs and drugs of abuse in a clinical specimen.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LAS | Drug Specific Control Materials |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Total Volume: 3 Milliliter |
Device Record Status
4f10c12f-1af6-4a9e-b27c-6f0ee32b297e
February 08, 2023
1
January 31, 2023
February 08, 2023
1
January 31, 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 |
---|---|---|---|---|---|
B800UTAKUCDEXSD5 | 17 | B800UTAKUCDEXSD0 | In Commercial Distribution | 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
[?]
1-888-882-5522
welovecontrol@utak.com
welovecontrol@utak.com