AVANOS - Turbo-Cleaning Closed Suction System for Adults, - Avanos Medical, Inc.

Duns Number:079375431

Device Description: Turbo-Cleaning Closed Suction System for Adults, DSE, MDI

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More Product Details

Catalog Number

22714183

Brand Name

AVANOS

Version/Model Number

99747

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)

-

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

BSY

Product Code Name

CATHETERS, SUCTION, TRACHEOBRONCHIAL

Device Record Status

Public Device Record Key

99924db0-1239-415a-a715-2e3affde1817

Public Version Date

May 15, 2020

Public Version Number

1

DI Record Publish Date

May 07, 2020

Additional Identifiers

Package DI Number

10609038997473

Quantity per Package

10

Contains DI Package

00609038997476

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

DSP

"AVANOS MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 269
2 A medical device with a moderate to high risk that requires special controls. 5221