Catalog Number

RP-1011

Brand Name

25ft O2 Delivery Tube TAV, 1PK

Version/Model Number

RP-1011

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

-

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

K152664,K152664

Product Code

ONZ

Product Code Name

Mechanical Ventilator

Public Device Record Key

d17d7f10-db08-4b67-b902-78e2e2ac474c

Public Version Date

August 05, 2022

Public Version Number

2

DI Record Publish Date

March 20, 2020

Package DI Number

00817131020339

Quantity per Package

2

Contains DI Package

00817131020391

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

RP-1002