Catalog Number

-

Brand Name

Assy, 25' Pulmo Chest Bellows

Version/Model Number

A01A103LONG

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

HCC

Product Code Name

Device, Biofeedback

Public Device Record Key

107e8ec8-6d20-4815-8acb-ebc15b2148a5

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 20, 2017

Package DI Number

10851607003119

Quantity per Package

1

Contains DI Package

00851607003112

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

shipper