GUDID 00763000044060

TRANSDUCER 95184-001 BIO-PROBE TX-50 FA

MEDTRONIC, INC.

Blood flowmeter transducer, non-indwelling

• Primary Device ID: 00763000044060
• NIH Device Record Key: f30b77bf-1bb3-464b-88bf-f11da02f6c69
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 95184-001
• Company DUNS: 006261481
• Company Name: MEDTRONIC, 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: false
• Lot Batch: false
• Serial Number: true
• 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

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Outer Diameter: 9.53 Millimeter
• Outer Diameter: 9.53 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between -34 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 66 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000044060 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K924208

FDA Product Code

• DPT: PROBE, BLOOD-FLOW, EXTRAVASCULAR

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: 2018-10-10
• Device Publish Date: 2018-01-20

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