HemosIL AcuStar Cleaning Solution - HemosIL AcuStar Cleaning Solution - INSTRUMENTATION LABORATORY COMPANY

Duns Number:557223252

Device Description: HemosIL AcuStar Cleaning Solution

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More Product Details

Catalog Number

0009802204

Brand Name

HemosIL AcuStar Cleaning Solution

Version/Model Number

0009802204

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

-

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

-

Product Code Details

Product Code

JPA

Product Code Name

SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES

Device Record Status

Public Device Record Key

075e9f39-1fb6-4473-8262-2b5479f0893d

Public Version Date

July 14, 2021

Public Version Number

5

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INSTRUMENTATION LABORATORY COMPANY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 18
2 A medical device with a moderate to high risk that requires special controls. 272