Bivona - SMITHS MEDICAL ASD, INC.

Duns Number:118112924

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Bivona

Version/Model Number

855160

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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,K912469

Product Code Details

Product Code

BTO

Product Code Name

Tube, tracheostomy (w/wo connector)

Device Record Status

Public Device Record Key

1a74b61b-55c9-4c90-b091-e20f7f8c3652

Public Version Date

June 05, 2020

Public Version Number

4

DI Record Publish Date

September 01, 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