Catalog Number

00020006900

Brand Name

HemosIL Calcium Chloride 0.020M (for SynthASil SynthAFax)

Version/Model Number

00020006900

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 30, 2019

Issuing Agency

In GS1

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K060688,K060688

Product Code

GFO

Product Code Name

ACTIVATED PARTIAL THROMBOPLASTIN

Public Device Record Key

0c5eb3b3-a0cd-438f-9223-fe55a74d04e3

Public Version Date

July 13, 2021

Public Version Number

6

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-