Embrace TALK Blood Glucose Monitor (Pre-Pack) - OMNIS HEALTH, LLC

Duns Number:824763358

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More Product Details

Catalog Number

-

Brand Name

Embrace TALK Blood Glucose Monitor (Pre-Pack)

Version/Model Number

APX03AB0300PRE

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K090043

Product Code Details

Product Code

LFR

Product Code Name

Glucose Dehydrogenase, Glucose

Device Record Status

Public Device Record Key

094a5e62-ce88-4e84-9eb5-49728213c3f1

Public Version Date

December 10, 2019

Public Version Number

1

DI Record Publish Date

December 02, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OMNIS HEALTH, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5
2 A medical device with a moderate to high risk that requires special controls. 12