IDKIT: HP ONE - The IDKIT: HP ONE contain 25 units of ID Circuit - MERIDIAN BIOSCIENCE ISRAEL LTD

Duns Number:514832786

Device Description: The IDKIT: HP ONE contain 25 units of ID Circuit (cannula). The ID Circuit is used to coll The IDKIT: HP ONE contain 25 units of ID Circuit (cannula). The ID Circuit is used to collect the breath sample from the patient.

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More Product Details

Catalog Number

-

Brand Name

IDKIT: HP ONE

Version/Model Number

AC00051

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

K173772,K173772,K173772,K173772

Product Code Details

Product Code

-

Product Code Name

-

Device Record Status

Public Device Record Key

43e5b6ba-8db6-4313-8b56-2725e5c2b75a

Public Version Date

December 23, 2021

Public Version Number

1

DI Record Publish Date

December 15, 2021

Additional Identifiers

Package DI Number

70350402100136

Quantity per Package

4

Contains DI Package

00350402100137

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"MERIDIAN BIOSCIENCE ISRAEL LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3