Volume probe

GUDID 06945121400220

CHISON Medical Technologies Co., Ltd.

Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe Foetal Doppler system probe

• Primary Device ID: 06945121400220
• NIH Device Record Key: d8bf250f-0bf3-47de-a2c9-65d0d15f7917
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Volume probe
• Version Model Number: V4C40L
• Company DUNS: 544914187
• Company Name: CHISON Medical Technologies Co., Ltd.
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	06945121400220 [Primary]
GS1	06945121410755 [Package]; Package: [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153085

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [Volume probe]

• 06945121410175: V6-EV
• 06945121410168: V4-EV
• 06945121406642: V4C40L-C
• 06945121400237: V6C10L
• 06945121400220: V4C40L
• 06945121413534: VE6-T
• 06945121413770: VC4-T