Medex

GUDID 35019315093375

SMITHS MEDICAL GROUP LTD

Electrical-only medical device connection cable, reusable

• Primary Device ID: 35019315093375
• NIH Device Record Key: f355086c-9d9e-4e15-8626-28aa80e6f036
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medex
• Version Model Number: MX961Z02P1
• Company DUNS: 738829485
• Company Name: SMITHS MEDICAL GROUP 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: true
• Serial Number: false
• Manufacturing Date: false
• 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	35019315093375 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K961404

FDA Product Code

• DRS: Transducer, blood-pressure, extravascular

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-13
• Device Publish Date: 2019-12-05

On-Brand Devices [Medex]

• 35019315093528: MX962Z02P1
• 35019315093375: MX961Z02P1
• 15019315093517: MX962Y68