Catalog Number

-

Brand Name

Kiwi® OmniCup®

Version/Model Number

VAC-6000ME

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

K981260,K981260,K981260

Product Code

HDB

Product Code Name

Extractor, Vacuum, Fetal

Public Device Record Key

aadb193a-6437-4fd7-9d6b-554c6d15d0e3

Public Version Date

February 21, 2019

Public Version Number

4

DI Record Publish Date

September 01, 2016

Package DI Number

20814247020639

Quantity per Package

12

Contains DI Package

10814247020632

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-