DEVICE: Pentobarbital (B800663190)
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? |
|---|---|---|---|---|
| 55758 | Phenobarbital 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 phenobarbital 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: 5 Milliliter |
Device Record Status
509354f8-9263-44b5-a514-9871c71ac8fa
April 23, 2020
1
April 15, 2020
April 23, 2020
1
April 15, 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 |
|---|---|---|---|---|---|
| B800663195 | 5 | B800663190 | 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
[?]
888-882-5522
welovecontrol@utak.com
welovecontrol@utak.com