Mullins Transseptal

GUDID 00643169014756

INTRODUCER 008532 MULLIN TRANS CATH 8F P

MEDTRONIC, INC.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 00643169014756
• NIH Device Record Key: 2a6488cb-4beb-4339-8e70-5c3fde3b01c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mullins Transseptal
• Version Model Number: 008532
• 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
• 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
• 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 Dimensions

• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Outer Diameter: 0.64 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Outer Diameter: 0.64 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Outer Diameter: 0.64 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Outer Diameter: 0.64 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Outer Diameter: 0.64 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Outer Diameter: 0.64 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Outer Diameter: 0.64 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Outer Diameter: 0.64 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Outer Diameter: 0.64 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Outer Diameter: 0.64 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Outer Diameter: 0.64 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Outer Diameter: 0.64 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Outer Diameter: 0.64 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Outer Diameter: 0.64 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Outer Diameter: 0.64 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Outer Diameter: 0.64 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Outer Diameter: 0.64 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Outer Diameter: 0.64 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Outer Diameter: 0.64 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Outer Diameter: 0.64 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Outer Diameter: 0.64 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Outer Diameter: 0.64 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Outer Diameter: 0.64 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Outer Diameter: 0.64 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Outer Diameter: 0.64 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Outer Diameter: 0.64 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Outer Diameter: 0.64 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Outer Diameter: 0.64 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Outer Diameter: 0.64 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Outer Diameter: 0.64 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Outer Diameter: 0.64 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Outer Diameter: 0.64 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Outer Diameter: 0.64 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Outer Diameter: 0.64 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169014756 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K791963

FDA Product Code

• DYB: INTRODUCER, CATHETER

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-06-07
• Device Publish Date: 2017-02-02

On-Brand Devices [Mullins Transseptal]

• 00643169014763: INTRODUCER 008531 MULLIN TRAN CATH 7F P
• 00643169014756: INTRODUCER 008532 MULLIN TRANS CATH 8F P
• 00643169014749: CATH 008550 MULLINS TRANS CATH 6F AD
• 00643169014732: INTRODUCER 008551 MULLIN TRAN CATH 7F AD
• 00643169014725: INTRODUCER 008552 MULLIN TRAN CATH 8F AD