Catalog Number

-

Brand Name

Blom

Version/Model Number

313-11-100

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K062104,K062104

Product Code

BTO

Product Code Name

Tube, Tracheostomy (W/Wo Connector)

Public Device Record Key

b9b09ac2-1753-4e18-97b9-0d2646f01a66

Public Version Date

June 05, 2020

Public Version Number

4

DI Record Publish Date

November 13, 2015

Package DI Number

10841470103269

Quantity per Package

10

Contains DI Package

00841470103262

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-