DEVICE: EasyTouch (MHC18070012)

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Device Record History
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Device Identifier (DI) Information
EasyTouch
807001
In Commercial Distribution

MHC MEDICAL PRODUCTS, LLC
MHC18070012
HIBCC

1
169895245 *Terms of Use
No description.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
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?
47655 Home-use/point-of-care blood glucose/blood pressure monitoring system
A collection of devices designed to semi-quantitatively measure glucose in a specimen of whole blood in a short period, typically several minutes, and to noninvasively measure blood pressure. It typically consists of a portable analyser (a self-testing meter), reagents, test strips and accessories (e.g., a lancet), and a blood pressure cuff. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus. The device is normally available [non-prescription] over-the-counter (OTC) for home-use, but may also be used in a clinical setting for multi-patient monitoring of blood glucose and blood pressure.
Obsolete false
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FDA Product Code

[?]
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 [?]
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
2cf2799f-cbd3-4895-805c-ba1dd2fba018
March 29, 2018
2
August 01, 2016
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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
No Package DIs found
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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
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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