Catalog Number

-

Brand Name

N/A

Version/Model Number

RM21307

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

CAI

Product Code Name

Circuit, Breathing (W Connector, Adaptor, Y Piece)

Public Device Record Key

c18b4781-ca42-4374-be62-b0dc145d957b

Public Version Date

October 24, 2022

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

05030267114214

Quantity per Package

10

Contains DI Package

00619498213078

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-