Bivona - SMITHS MEDICAL ASD, INC.

Duns Number:118112924

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More Product Details

Catalog Number

-

Brand Name

Bivona

Version/Model Number

R67P040

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

K083641,K914088

Product Code Details

Product Code

JOH

Product Code Name

Tube tracheostomy and tube cuff

Device Record Status

Public Device Record Key

63b8a37f-a3d4-416e-86fb-31fb89a0a201

Public Version Date

June 05, 2020

Public Version Number

4

DI Record Publish Date

July 29, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SMITHS MEDICAL ASD, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 104
2 A medical device with a moderate to high risk that requires special controls. 36112