AVANOS - H9386102EN ENFit Bax AdaptaCap Size B - Avanos Medical, Inc.

Duns Number:079375431

Device Description: H9386102EN ENFit Bax AdaptaCap Size B

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More Product Details

Catalog Number

H9386102EN

Brand Name

AVANOS

Version/Model Number

H9386102EN

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

-

Product Code Details

Product Code

KYX

Product Code Name

DISPENSER, LIQUID MEDICATION

Device Record Status

Public Device Record Key

94f9452a-6621-469c-81da-a0d9a6be0bd9

Public Version Date

May 21, 2021

Public Version Number

1

DI Record Publish Date

May 13, 2021

Additional Identifiers

Package DI Number

10350770003051

Quantity per Package

16

Contains DI Package

00350770003054

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