Kiwi® OmniCup®

GUDID 20814247020639

Kiwi® Vacuum Delivery System, OmniCup®

CLINICAL INNOVATIONS, LLC

Foetal vacuum extraction system cup, single-use

• Primary Device ID: 20814247020639
• NIH Device Record Key: aadb193a-6437-4fd7-9d6b-554c6d15d0e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kiwi® OmniCup®
• Version Model Number: VAC-6000ME
• Company DUNS: 809524291
• Company Name: CLINICAL INNOVATIONS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814247020635 [Primary]
GS1	10814247020632 [Package]; Contains: 00814247020635; Package: [5 Units]; In Commercial Distribution
GS1	20814247020639 [Package]; Contains: 10814247020632; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K981260

FDA Product Code

• HDB: Extractor, Vacuum, Fetal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-21
• Device Publish Date: 2016-09-01

On-Brand Devices [Kiwi® OmniCup®]

• 20814247020653: Kiwi® Vacuum Delivery System, OmniCup® with Traction Force Indicator
• 20814247020646: Kiwi® Vacuum Delivery System, OmniCup® with Traction Force Indicator
• 20814247020639: Kiwi® Vacuum Delivery System, OmniCup®
• 20814247020004: Kiwi® Vacuum Delivery System, OmniCup®