HemaPrompt FG - HemaPrompt FG Fecal and Gastric Test Kit - AERSCHER, INC

Duns Number:926911454

Device Description: HemaPrompt FG Fecal and Gastric Test Kit

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More Product Details

Catalog Number

-

Brand Name

HemaPrompt FG

Version/Model Number

HPFG

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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

K972763,K972763

Product Code Details

Product Code

KHE

Product Code Name

Reagent, Occult Blood

Device Record Status

Public Device Record Key

3ee0047f-f755-4c89-8735-eb6e5aa346b0

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 05, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-