Catalog Number

-

Brand Name

MIDAS REX

Version/Model Number

PC720

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

K183515

Product Code

CAN

Product Code Name

REGULATOR, PRESSURE, GAS CYLINDER

Public Device Record Key

eb727918-f218-4ae2-a15a-c8a83cd0b07b

Public Version Date

June 17, 2019

Public Version Number

1

DI Record Publish Date

June 08, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-