Welby

GUDID 06947679701279

Shenzhen Pump Medical System Co., Ltd.

Patient monitoring system module, blood pressure, noninvasive

• Primary Device ID: 06947679701279
• NIH Device Record Key: 8b74b7a6-9a56-4b91-8b7b-05c2f82d2ee8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Welby
• Version Model Number: MD 14942
• Company DUNS: 421184626
• Company Name: Shenzhen Pump Medical System 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06947679701279 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141416

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive

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: 2017-06-01

Devices Manufactured by Shenzhen Pump Medical System Co., Ltd.

• 06947679700616 - PUMP: 2018-07-06
• 06947679701194 - IGuerburn: 2018-07-06
• 06947679701279 - Welby: 2018-07-06
• 06947679701279 - Welby: 2018-07-06
• 06947679701170 - IGuerburn: 2018-03-29