Catheter Passer

GUDID 00763000027841

PASSER 48409 60CM DISP. CATHETER

MEDTRONIC PS MEDICAL, INC.

Subcutaneous tunneller, single-use Subcutaneous tunneller, single-use Subcutaneous tunneller, single-use Subcutaneous tunneller, single-use Subcutaneous tunneller, single-use Subcutaneous tunneller, single-use Subcutaneous tunneller, single-use Subcutaneous tunneller, single-use Subcutaneous tunneller, single-use Subcutaneous tunneller, single-use Subcutaneous tunneller, single-use Subcutaneous tunneller, single-use Subcutaneous tunneller, single-use Subcutaneous tunneller, single-use Subcutaneous tunneller, single-use Subcutaneous tunneller, single-use Subcutaneous tunneller, single-use Subcutaneous tunneller, single-use

• Primary Device ID: 00763000027841
• NIH Device Record Key: d9b515c2-862d-4231-b98a-3ed9cac74108
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Catheter Passer
• Version Model Number: 48409
• Company DUNS: 089055867
• Company Name: MEDTRONIC PS MEDICAL, 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000027841 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K911382

FDA Product Code

• MAJ: Catheter, percutaneous, intraspinal, short term

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-13
• Device Publish Date: 2020-04-03

On-Brand Devices [Catheter Passer]

• 00763000031411: PASSER 8591-60 CATHETER-60CM
• 00763000031404: PASSER 8591-38 CATHETER-38CM
• 00763000027858: PASSER 48407 CATHETER 38CM DISP.
• 00763000027841: PASSER 48409 60CM DISP. CATHETER