Silicone Birth Vac Cup

GUDID 04711182604004

FORTUNE MEDICAL INSTRUMENT CORP.

Foetal vacuum extraction system cup, reusable

• Primary Device ID: 04711182604004
• NIH Device Record Key: 105ca7c6-fe44-4674-941b-d14cf83b3692
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silicone Birth Vac Cup
• Version Model Number: 1300-0050
• Company DUNS: 656763489
• Company Name: FORTUNE MEDICAL INSTRUMENT CORP.
• 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: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04711182604004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021193

FDA Product Code

• HDB: Extractor, Vacuum, Fetal

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-21
• Device Publish Date: 2016-03-10

On-Brand Devices [Silicone Birth Vac Cup]

• 04711182604004: 1300-0050
• 04710961930013: 1300-0070
• 04710961930006: 1300-0060