Center Health Blood Glucose Test Strips (50pcs/bot) - CENTER HEALTH INCORPORATED

Duns Number:080946441

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More Product Details

Catalog Number

-

Brand Name

Center Health Blood Glucose Test Strips (50pcs/bot)

Version/Model Number

TD-4140

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

K162382

Product Code Details

Product Code

LFR

Product Code Name

Glucose Dehydrogenase, Glucose

Device Record Status

Public Device Record Key

165e10c2-3e32-4087-a448-acef628e68ff

Public Version Date

March 25, 2020

Public Version Number

1

DI Record Publish Date

March 17, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CENTER HEALTH INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 3