DEVICE: ACCU-CHEK GUIDE (00365702702066)
Device Identifier (DI) Information
ACCU-CHEK GUIDE
07400942001
In Commercial Distribution
07400942001
Roche Diagnostics Operations, Inc.
07400942001
In Commercial Distribution
07400942001
Roche Diagnostics Operations, Inc.
ACCU-CHEK GUIDE METER ONLY MG/DL US
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
No | |
Yes | |
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? |
---|---|---|---|---|
53301 | Glucose IVD, kit, spectrophotometry |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of glucose in a clinical specimen, using a spectrophotometry method.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NBW | System, Test, Blood Glucose, Over The Counter |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K160944 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
96ee2869-4f5b-42c7-90bd-9d4b254d2f05
July 12, 2023
4
February 02, 2017
July 12, 2023
4
February 02, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10365702702063 | 20 | 00365702702066 | In Commercial Distribution |
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