ARES COC Cable - ARES CoC Cable - Watermark Medical, Inc.

Duns Number:017159127

Device Description: ARES CoC Cable

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More Product Details

Catalog Number

W14205

Brand Name

ARES COC Cable

Version/Model Number

610/620

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

MNR

Product Code Name

VENTILATORY EFFORT RECORDER

Device Record Status

Public Device Record Key

728f0699-5626-479c-bf9b-d5151042f579

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

May 19, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"WATERMARK MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 19