Bio-Probe™

GUDID 20643169802678

CON PROBE CB4627 BIOACT FLOW PEDIAT 10PK

MEDTRONIC, INC.

Blood flowmeter transducer, non-indwelling

• Primary Device ID: 20643169802678
• NIH Device Record Key: 6d14ee53-0a6c-45f0-8999-84f45e470749
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bio-Probe™
• Version Model Number: CB4627
• 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: true
• Single Use: true
• 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

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

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169630642 [Primary]
GS1	20643169802678 [Package]; Contains: 00643169630642; Package: PK [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132730

FDA Product Code

• DPT: PROBE, BLOOD-FLOW, EXTRAVASCULAR

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-21

On-Brand Devices [Bio-Probe™]

• 20643169802678: CON PROBE CB4627 BIOACT FLOW PEDIAT 10PK
• 20643169802661: PROBE CB2980POLY FLOW BIOACTIVE 10PK
• 20763000419909: PROBE CB4627 BIOACT FLOW PED 10PK
• 20763000419893: PROBE CB2980POLY FLOW BIOACTIVE 10PK