Medibio TD-4277 Blood Glucose Test Strips 50pcs - MEDIBIO USA LLC

Duns Number:012481654

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More Product Details

Catalog Number

-

Brand Name

Medibio TD-4277 Blood Glucose Test Strips 50pcs

Version/Model Number

TD-4277

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

LFR

Product Code Name

Glucose Dehydrogenase, Glucose

Device Record Status

Public Device Record Key

fc36b9a8-507a-4d34-badf-66e25265e7ad

Public Version Date

February 03, 2020

Public Version Number

1

DI Record Publish Date

January 24, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDIBIO USA LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 4