DEVICE: ACCU-CHEK GUIDE (00365702701977)

Device Identifier (DI) Information

ACCU-CHEK GUIDE
07453701001
In Commercial Distribution
07453701001
Roche Diagnostics Operations, Inc.
00365702701977
GS1

1
141608724 *Terms of Use
ACCU-CHEK GUIDE 10CT STRIP 36/CS
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
Yes
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Glucose IVD, reagent A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of glucose in a clinical specimen.
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FDA Product Code

[?]
Product Code Product Code Name
LFR Glucose Dehydrogenase, Glucose
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K160944 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

45ee28bb-3380-40fa-8735-f83423cd9bec
July 06, 2018
3
February 02, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10365702701974 36 00365702701977 In Commercial Distribution
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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