Catalog Number

P1257

Brand Name

Pro-Tech

Version/Model Number

PRO-FLOW

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

December 31, 9999

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K982293,K982293,K982293

Product Code

MNR

Product Code Name

VENTILATORY EFFORT RECORDER

Public Device Record Key

953913ad-4c19-449d-ae06-40eed1352cdb

Public Version Date

March 22, 2022

Public Version Number

4

DI Record Publish Date

September 30, 2016

Package DI Number

40606959032208

Quantity per Package

10

Contains DI Package

00606959032200

Package Discontinue Date

December 31, 1999

Package Status

Not in Commercial Distribution

Package Type

Multipack