HemosIL Rinse Solution (ACL Futura Advance) - HemosIL Rinse Solution (ACL Futura Advance) 2 LIT - INSTRUMENTATION LABORATORY COMPANY

Duns Number:557223252

Device Description: HemosIL Rinse Solution (ACL Futura Advance) 2 LIT

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More Product Details

Catalog Number

00020009320

Brand Name

HemosIL Rinse Solution (ACL Futura Advance)

Version/Model Number

00020009320

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 09, 2018

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)

-

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

880a729c-2f39-4e62-a18c-4b3738328b9d

Public Version Date

July 09, 2021

Public Version Number

3

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