Catalog Number

43031S9701

Brand Name

RECEPTAL™ 3000 ML LINER WITH (2) PORTS

Version/Model Number

1

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

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

-

Product Code

GCX

Product Code Name

Apparatus, Suction, Operating-Room, Wall Vacuum Powered

Public Device Record Key

0a4b0653-8c04-4712-b1a5-704138c1587f

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 18, 2017

Package DI Number

40704411007068

Quantity per Package

5

Contains DI Package

20704411007064

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case