MC3 - Soft Flow Aortic 21 FR 7MM STRAIGHT BULB VENTED - MICHIGAN CRITICAL CARE CONSULTANTS, INC.

Duns Number:806687406

Device Description: Soft Flow Aortic 21 FR 7MM STRAIGHT BULB VENTED

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More Product Details

Catalog Number

5798

Brand Name

MC3

Version/Model Number

5798

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

Yes

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

K132451,K132451,K132451

Product Code Details

Product Code

DWF

Product Code Name

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Device Record Status

Public Device Record Key

892c37a0-f453-4c7f-83bf-3627dfb3e4e7

Public Version Date

August 05, 2022

Public Version Number

4

DI Record Publish Date

January 10, 2018

Additional Identifiers

Package DI Number

20854916006571

Quantity per Package

10

Contains DI Package

10854916006567

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"MICHIGAN CRITICAL CARE CONSULTANTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 38