Duns Number:809524291
Device Description: Kiwi® Vacuum Delivery System, OmniCup® with Traction Force Indicator
Catalog Number
-
Brand Name
Kiwi® OmniCup®
Version/Model Number
VAC-6000MT
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
bb255d00-74e3-4a3f-8651-7fc72e4468b0
Public Version Date
February 21, 2019
Public Version Number
4
DI Record Publish Date
September 01, 2016
Package DI Number
20814247020646
Quantity per Package
12
Contains DI Package
10814247020649
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 12 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 36 |