Catalog Number

768968

Brand Name

3100

Version/Model Number

768968

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"

Yes

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

P890057

Product Code

LSZ

Product Code Name

Ventilator, High Frequency

Public Device Record Key

f5b3cd8b-555e-476d-a9f9-1ff51366fd30

Public Version Date

June 07, 2019

Public Version Number

4

DI Record Publish Date

June 16, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-