Catalog Number

800-0546

Brand Name

PerFuse™ Decompression System

Version/Model Number

800-0546

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

K141762

Product Code

FMF

Product Code Name

Syringe, piston

Public Device Record Key

9b916406-b4bb-482e-89fa-c5e1524a2f1b

Public Version Date

September 16, 2022

Public Version Number

8

DI Record Publish Date

April 18, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-