Catalog Number

U1VNI1001

Brand Name

ECLERIS NIV HELMET

Version/Model Number

R00

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FOG

Product Code Name

Hood, Oxygen, Infant

Public Device Record Key

c4c2e4da-cf83-481f-be9a-29bb9cb8fff8

Public Version Date

July 08, 2022

Public Version Number

1

DI Record Publish Date

June 30, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-