AVANOS - BALLARD* Oral Suction Catheters - Avanos Medical, Inc.

Duns Number:079375431

Device Description: BALLARD* Oral Suction Catheters

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More Product Details

Catalog Number

1222

Brand Name

AVANOS

Version/Model Number

93882

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

JOL

Product Code Name

CATHETER AND TIP, SUCTION

Device Record Status

Public Device Record Key

596b50ca-5e42-45a2-ace9-cd2bddaf4d03

Public Version Date

July 02, 2020

Public Version Number

1

DI Record Publish Date

June 24, 2020

Additional Identifiers

Package DI Number

10609038938827

Quantity per Package

250

Contains DI Package

00609038938820

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS

"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