DEVICE: Mckesson (10612479250441)

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Device Record History
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Device Identifier (DI) Information
Mckesson
06-R5051-2
In Commercial Distribution

MCKESSON MEDICAL-SURGICAL INC.
10612479250441
GS1

1
023904428 *Terms of Use
CONTROL, BLD GLUCOSE LEVEL 2 T
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Device Characteristics
Labeling does not contain MRI Safety Information
No
Yes
No
No
Yes
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?
60740 Home-use blood glucose spot-check system
An electrically-powered, portable device assembly intended to spot-check (user-initiated) measure and display blood glucose concentration in a patient with diabetes mellitus; it is not intended for continuous measurements (i.e., not a monitor). It includes a quantitative glucose meter that uses a blood specimen for the personal calibration of a noninvasive qualitative measurement device (e.g., near-infrared spectroscopy) which performs the measurements, typically on a finger, without blood draw; it also includes test strips, lancets, control solutions, and associated materials. It is designed to be used by a layperson in the home, and some types may in addition be used at the point-of-care.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
NBW System, Test, Blood Glucose, Over The Counter
LFR Glucose Dehydrogenase, Glucose
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

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
4c201141-3c80-4ae6-9bb1-79e3a22958b9
September 09, 2020
2
August 19, 2020
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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
20612479197354 1 10612479250441 In Commercial Distribution Box
40612479197365 24 20612479197354 In Commercial Distribution Case
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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

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Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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