Catalog Number

-

Brand Name

Respironics Domed (Gherkin)

Version/Model Number

3400/01AIUA058/0001

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K040712,K040712

Product Code

MOD

Product Code Name

Accessory To Continuous Ventilator (Respirator)

Public Device Record Key

c219ac7c-7857-4ace-8613-fa4d54ecc671

Public Version Date

September 22, 2020

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

25060120952534

Quantity per Package

150

Contains DI Package

15060120952537

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box