Catalog Number

-

Brand Name

Sunmed Inflation Device

Version/Model Number

J Type, 28ml, 40atm/bar

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

PTM

Product Code Name

Syringe, Balloon Inflation, Exempt

Public Device Record Key

3ba47d01-0690-4108-a787-b6583973bffd

Public Version Date

January 12, 2022

Public Version Number

1

DI Record Publish Date

January 04, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-