DEVICE: ACCU-CHEK GUIDE (00365702702066)

Device Identifier (DI) Information

ACCU-CHEK GUIDE
07400942001
In Commercial Distribution
07400942001
Roche Diagnostics Operations, Inc.
00365702702066
GS1

1
141608724 *Terms of Use
ACCU-CHEK GUIDE METER ONLY MG/DL US
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Device Characteristics

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

GMDN

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

GMDN Preferred Term Name GMDN Definition
Home-use/point-of-care glucose analyser IVD, battery-powered An exclusively battery-powered instrument intended to be used by a layperson in the home or similar environment, or by health professionals at the point-of-care, for the quantitative in vitro measurement of glucose levels in whole blood. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus. This analyser is typically included in a blood glucose monitoring system.
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FDA Product Code

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Product Code Product Code Name
NBW System, Test, Blood Glucose, Over The Counter
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K160944 000
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Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

96ee2869-4f5b-42c7-90bd-9d4b254d2f05
July 06, 2018
3
February 02, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10365702702063 20 00365702702066 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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

[?]
Yes
Yes
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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