Catalog Number

70105.2794

Brand Name

NA

Version/Model Number

HLS Set Advanced 7.0, Adult, BIOLINE Coating

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

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

K112360

Product Code

DTR

Product Code Name

HEAT-EXCHANGER, CARDIOPULMONARY BYPASS

Public Device Record Key

60412e6f-6015-4a9d-8b6f-0b0d8e11d81e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 12, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-