Catalog Number

66020971

Brand Name

RENASYS® Y-Connector

Version/Model Number

66020971

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K181204,K181204

Product Code

OMP

Product Code Name

Negative Pressure Wound Therapy Powered Suction Pump

Public Device Record Key

e9c0fc49-9e47-4ae6-b80d-a7d2c4713272

Public Version Date

June 21, 2021

Public Version Number

4

DI Record Publish Date

January 24, 2019

Package DI Number

05000223493608

Quantity per Package

10

Contains DI Package

05000223493592

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case