Catalog Number

-

Brand Name

ARC Medical

Version/Model Number

6001T

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"

Yes

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

-

Product Code

OFP

Product Code Name

Anesthesia Breathing Circuit Kit (Adult & Pediatric)

Public Device Record Key

fad6b0c5-717a-401e-995f-05b838f46208

Public Version Date

September 03, 2021

Public Version Number

1

DI Record Publish Date

August 26, 2021

Package DI Number

10810050853894

Quantity per Package

100

Contains DI Package

00810050853897

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case