GUDID 00763000044077

TRANSDUCER 95185-001 BIO-PROBE TX-50P FA

MEDTRONIC, INC.

Blood flowmeter transducer, non-indwelling Blood flowmeter transducer, non-indwelling

• Primary Device ID: 00763000044077
• NIH Device Record Key: db09b5f0-7b37-4ca0-8c74-0cf67f69e988
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 95185-001
• 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: 6.35 Millimeter
• Outer Diameter: 6.35 Millimeter

Operating and Storage Conditions

• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000044077 [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

Devices Manufactured by MEDTRONIC, INC.

• 00763000957544 - NA: 2024-06-28 CUSTOM PACK BB7J30R4 LIV SHUNT
• 00763000957551 - NA: 2024-06-28 CUSTOM PACK BBB7S09R13 SUPPRT SM
• 20763000957760 - NA: 2024-06-28 CUSTOM PACK BB12G13R 5PK FL MEM MANIFOL
• 00763000957780 - NA: 2024-06-28 CUSTOM PACK 11H88R7 ACCESSORY PACK
• 00763000958015 - NA: 2024-06-28 CUSTOM PACK HY11R06R2 SUPP 1/4 PK
• 20763000958033 - NA: 2024-06-28 CUSTOM PACK BB9B82R2 5PK JUMP PACK
• 00763000958695 - NA: 2024-06-28 CUSTOM PACK BB11F32R5 ACCESSORY 1/4
• 00763000958701 - NA: 2024-06-28 CUSTOM PACK BB12F79R2 NT PK