Catalog Number

DS103

Brand Name

Bound Tree

Version/Model Number

DS103

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

K014071,K014071

Product Code

BTM

Product Code Name

Ventilator, Emergency, Manual (Resuscitator)

Public Device Record Key

a8b3e25f-39e9-4939-994d-09685ac4add5

Public Version Date

February 20, 2020

Public Version Number

5

DI Record Publish Date

December 09, 2015

Package DI Number

40026072000210

Quantity per Package

16

Contains DI Package

00026072000212

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case