Catalog Number

1078535

Brand Name

NeoPAP Bonnet - XS

Version/Model Number

1078535

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)

-

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

K103410,K103410

Product Code

BZD

Product Code Name

Ventilator, Non-Continuous (Respirator)

Public Device Record Key

0d9074f1-279d-49a5-9a51-900b64512011

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 29, 2016

Package DI Number

B0361074083

Quantity per Package

10

Contains DI Package

B0361078535

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Single