Z2

GUDID 00613994814913

CATHETER Z28SL50SH Z2 8F 100CM SL50

MEDTRONIC, INC.

Vascular guide-catheter, single-use

• Primary Device ID: 00613994814913
• NIH Device Record Key: 50b7532a-8bb5-406f-8f73-639a7e6c4ff1
• Commercial Distribution Discontinuation: 2017-08-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Z2
• Version Model Number: Z28SL50SH
• 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

Device Dimensions

• Length: 100 Centimeter
• Length: 100 Centimeter
• Length: 100 Centimeter
• Length: 100 Centimeter
• Length: 100 Centimeter
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 100 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994814913 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982883

FDA Product Code

• DQY: CATHETER, PERCUTANEOUS

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-01-23
• Device Publish Date: 2016-04-28

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• 00613994817518: CATHETER ZM5FL60 Z2 5F 100CM FL60
• 00613994817501: CATHETER ZM5FL50 Z2 5F 100CM FL50
• 00613994817495: CATHETER ZM5FL45 Z2 5F 100CM FL45
• 00613994817488: CATHETER ZM5FL40 Z2 5F 100CM FL40
• 00613994817471: CATHETER ZM5FL35 Z2 5F 100CM FL35
• 00613994817464: CATHETER ZM5FL30 Z2 5F 100CM FL30
• 00613994817457: CATHETER ZM5JCR50 Z2 5F 100CM JCR50
• 00613994817440: CATHETER ZM5JCR45 Z2 5F 100CM JCR45
• 00613994817433: CATHETER ZM5JCR40 Z2 5F 100CM JCR40
• 00613994817426: CATHETER ZM5JCR35 Z2 5F 100CM JCR35
• 00613994817419: CATHETER ZM5JCL50 Z2 5F 100CM JCL50
• 00613994817402: CATHETER ZM5JCL45 Z2 5F 100CM JCL45
• 00613994817396: CATHETER ZM5JCL40 Z2 5F 100CM JCL40
• 00613994817389: CATHETER ZM5JCL35 Z2 5F 100CM JCL35
• 00613994817372: CATHETER ZM5JCL30 Z2 5F 100CM JCL30
• 00613994817365: CATHETER ZM5IMAD Z2 5F 90CM IMA
• 00613994817358: CATHETER ZM5IMA Z2 5F 100CM IMA
• 00613994817341: CATHETER ZM5HSIII Z2 5F 100CM HSIII
• 00613994817334: CATHETER ZM5HSII Z2 5F 100CM HSII
• 00613994817327: CATHETER ZM5CHAMP05 Z2 5F 100CM CH05
• 00613994817310: CATHETER ZM5AR20 Z2 5F 100CM AR20
• 00613994817303: CATHETER ZM5AR10 Z2 5F 100CM AR10
• 00613994817297: CATHETER ZM5ALR12 Z2 5F 100CM ALR12
• 00613994817280: CATHETER ZM5AL75 Z2 5F 100CM AL75
• 00613994817273: CATHETER ZM5AL40 Z2 5F 100CM AL40
• 00613994817266: CATHETER ZM5AL30 Z2 5F 100CM AL30
• 00613994817259: CATHETER ZM5AL25 Z2 5F 100CM AL25
• 00613994817242: CATHETER ZM5AL20 Z2 5F 100CM AL20
• 00613994817235: CATHETER ZM5AL15 Z2 5F 100CM AL15
• 00613994817228: CATHETER ZM5AL10 Z2 5F 100CM AL10
• 00613994817211: CATHETER ZM53DRIGHT Z2 5F 100CM 3DRGT
• 00613994817204: CATHETER ZM53DRC Z2 5F 100CM 3DRC
• 00613994817198: CATHETER ZM5ELGAMAL Z2 5F 100CM EG
• 00613994817181: CATHETER ZM5EBU50 Z2 5F 100CM EB50
• 00613994817174: CATHETER ZM5EBU45 Z2 5F 100CM EB45
• 00613994817167: CATHETER ZM5EBU40 Z2 5F 100CM EB40
• 00613994817150: CATHETER ZM5EBU375 Z2 5F 100CM EB375
• 00613994817143: CATHETER ZM5EBU35 Z2 5F 100CM EB35