Marinr™

GUDID 00613994947192

CATH 043325M MARINR USA CS W/O CE

MEDTRONIC, INC.

Cardiac mapping catheter, percutaneous, single-use

• Primary Device ID: 00613994947192
• NIH Device Record Key: 27edbd18-c001-4884-a690-b6a81accc199
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Marinr™
• Version Model Number: 043325M
• 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: 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: true
• 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
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994947192 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K951347

FDA Product Code

• DRF: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

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: 2016-04-15

On-Brand Devices [Marinr™]

• 00613994947543: CATH 043302M MARINR USA CS W/O CE
• 00613994947239: CATH 072402 MARINR USA MCXL W/O CE
• 00613994947222: CATH 072322M MARINR USA SCXXL W/O CE
• 00613994947215: CATH 072302 MARINR USA MC W/O CE
• 00613994947208: CATH 043328M MARINR USA CS W/O CE
• 00613994947192: CATH 043325M MARINR USA CS W/O CE
• 00763000227890: CATH 072322M MARINR SCXXL W/O CE
• 00763000227869: CATH 043302M MARINR CS W/O CE
• 00763000227852: CATH 043325M MARINR CS W/O CE
• 00763000227845: CATH 043328M MARINR CS W/O CE
• 00763000227883: CATH 072302 MARINR MC W/O CE
• 00763000227876: CATH 072402 MARINR MCXL W/O CE