FIA Salut foil packed test strip(for SS) - FIA Salut Blood Glucose KPH foil packed test - HMD BIOMEDICAL INC.

Duns Number:658644174

Device Description: FIA Salut Blood Glucose KPH foil packed test strip(for SS)

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More Product Details

Catalog Number

3L-10-14003A

Brand Name

FIA Salut foil packed test strip(for SS)

Version/Model Number

3L-10-14003A

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K121433,K121433

Product Code Details

Product Code

LFR

Product Code Name

Glucose Dehydrogenase, Glucose

Device Record Status

Public Device Record Key

89fb057a-ebaf-485d-9285-61b891683493

Public Version Date

July 27, 2020

Public Version Number

1

DI Record Publish Date

July 17, 2020

Additional Identifiers

Package DI Number

04260236851289

Quantity per Package

180

Contains DI Package

04260236850459

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

FOIL

"HMD BIOMEDICAL INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 15
2 A medical device with a moderate to high risk that requires special controls. 16