Catalog Number

951001

Brand Name

IntelliCuff

Version/Model Number

951001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

-

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

K150893

Product Code

BSK

Product Code Name

Cuff, Tracheal Tube, Inflatable

Public Device Record Key

b3323140-743c-4d7d-b248-4a67135630cf

Public Version Date

January 28, 2022

Public Version Number

6

DI Record Publish Date

April 13, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-