Catalog Number

65652-543B

Brand Name

MEDI-VAC

Version/Model Number

65652-543B

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)

-

Over the Counter (OTC)

Yes

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

3c5d8d73-0f18-4eb2-80c1-02eeb80c3e70

Public Version Date

February 21, 2020

Public Version Number

2

DI Record Publish Date

December 13, 2018

Package DI Number

90885380167061

Quantity per Package

25

Contains DI Package

50885380167063

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE