MC3 Nautilus Power Cord NEMA - Power Cord (NEMA 5-5, 5m) for Nautilus Smart - MICHIGAN CRITICAL CARE CONSULTANTS, INC.

Duns Number:806687406

Device Description: Power Cord (NEMA 5-5, 5m) for Nautilus Smart ECMO Module

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More Product Details

Catalog Number

48155

Brand Name

MC3 Nautilus Power Cord NEMA

Version/Model Number

48155

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

K191935

Product Code Details

Product Code

BYS

Product Code Name

Oxygenator, Long Term Support Greater Than 6 Hours

Device Record Status

Public Device Record Key

c54bc0ca-8c1f-4ab6-a328-0784003cce40

Public Version Date

May 11, 2020

Public Version Number

1

DI Record Publish Date

May 01, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

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