BIO-PROBE®

GUDID 00643169315792

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

MEDTRONIC, INC.

Blood flowmeter transducer, non-indwelling

• Primary Device ID: 00643169315792
• NIH Device Record Key: 1b4fec7a-4152-496e-91a7-936235f6ba9d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIO-PROBE®
• 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

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	00643169315792 [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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-04-28

On-Brand Devices [BIO-PROBE®]

• 00643169315815: TRANSDUCER 95185-003 BIO PROBE TX50
• 00643169315808: TRANSDUCER 95185-002 BIO PROBE TX50
• 00643169315792: TRANSDUCER 95185-001 BIO-PROBE TX-50P FA
• 00643169315785: TRANSDUCER 95184-003 BIO-PROBE TX-50 FA
• 00643169315778: TRANSDUCER 95184-002 TX-50
• 00643169315761: TRANSDUCER 95184-001 BIO-PROBE TX-50 FA
• 00681490409254: TRANSDUCER 95185-001 BIO-PROBE 1EA TX-50
• 00681490409209: TRANSDUCER 95184-002 BIO-PROBE 1EA TX-50
• 00681490409186: TRANSDUCER 95184-001 BIO-PROBE 1EA TX-50
• 10681490408667: PROBE 95134 BIO-PROBE DP-38P ST 12PK 10L
• 20673978563330: CONN PROBE CB4627 BIOACT FLOW PEDIATRIC
• 00673978170640: RECON FINAL ASSY R95184-01 TX50 ADULT 5L
• 00673978169903: TRANSDUCER E95184-01 FA BIO PROBE TX50
• 00673978166933: TRANSDUCER 95185-003 BIO PROBE TX50
• 00673978166926: TRANSDUCER 95185-002 BIO-PROBE TX-50
• 20721902987780: PROBE CB2980POLY FLOW BIOACTIVE 10PK
• 20885074495747: PROBE 95244 BIO-PROBE 12PK DP38 ST PLYC