Mityvac

GUDID 30888937003032

Pearl Edge Bell Cup Vacuum-Assist Delivery System

Coopersurgical, Inc.

Foetal vacuum extraction system cup, single-use

• Primary Device ID: 30888937003032
• NIH Device Record Key: 584ac8cf-4808-4a0b-8c99-a9c386ca6262
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mityvac
• Version Model Number: 10004
• Company DUNS: 801895244
• Company Name: Coopersurgical, Inc.
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888937003031 [Primary]
GS1	20888937003035 [Package]; Contains: 00888937003031; Package: Box [12 Units]; In Commercial Distribution
GS1	30888937003032 [Package]; Contains: 00888937003031; Package: Case [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011532

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: 2016-08-30

On-Brand Devices [Mityvac]

• 00888937003154: Reusable vacuum extraction cup
• 00888937003147: Reusable Obstetrical Vacuum Pump
• 30888937003094: M-Select Mushroom Cup Vacuum-Assist Delivery System
• 20888937003080: MitySoft Bell Cup with Universal Vacuum Release (UVR) Vacuum-Assist Delivery System
• 30888937003070: MitySoft Bell Cup Vacuum-Assist Delivery System
• 20888937003066: M-Style Mushroom Cup Vacuum-Assist Delivery System with Universal Vacuum Release (UVR)
• 30888937003056: Mityvac Vacuum-Assist Delivery System Super M-Style® Mushroom Cup Vacuum-Assist Delivery System
• 30888937003049: M-Style Mushroom Cup Vacuum-Assist Delivery System
• 30888937003032: Pearl Edge Bell Cup Vacuum-Assist Delivery System