Catalog Number

-

Brand Name

T-PIECE ADAPTER

Version/Model Number

1

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

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

-

Product Code

BYP

Product Code Name

Mouthpiece, Breathing

Public Device Record Key

e1b5f1bb-92b4-44f1-8a7a-97dd07279edb

Public Version Date

March 23, 2020

Public Version Number

2

DI Record Publish Date

August 23, 2019

Package DI Number

30851232007678

Quantity per Package

10

Contains DI Package

10851232007674

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE