Catalog Number

1078667

Brand Name

NeoPAP Mask - S

Version/Model Number

1078667

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"

Yes

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

7b51fd54-edba-4229-8754-9fadbbd1d23c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 29, 2016

Package DI Number

B0361074125

Quantity per Package

10

Contains DI Package

B0361078667

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Single