SHERPA NX ACTIVE

GUDID 00613994781345

CATHETER SA5FL45 SA 5F 100CM FL45

MEDTRONIC, INC.

Vascular guide-catheter, single-use

• Primary Device ID: 00613994781345
• NIH Device Record Key: c2ce60cb-754b-483e-8439-259f81902402
• Commercial Distribution Discontinuation: 2017-08-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: SHERPA NX ACTIVE
• Version Model Number: SA5FL45
• 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
• 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
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Length: 100 Centimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Length: 100 Centimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Length: 100 Centimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Length: 100 Centimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Length: 100 Centimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Length: 100 Centimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Length: 100 Centimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Length: 100 Centimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Length: 100 Centimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Length: 100 Centimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Length: 100 Centimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Length: 100 Centimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Length: 100 Centimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Length: 100 Centimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Length: 100 Centimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Length: 100 Centimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Length: 100 Centimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Length: 100 Centimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Length: 100 Centimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Length: 100 Centimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Length: 100 Centimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Length: 100 Centimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Length: 100 Centimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Length: 100 Centimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Length: 100 Centimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Length: 100 Centimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Length: 100 Centimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Length: 100 Centimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Length: 100 Centimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Length: 100 Centimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Length: 100 Centimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Length: 100 Centimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Length: 100 Centimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Length: 100 Centimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Length: 100 Centimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Length: 100 Centimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Length: 100 Centimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Length: 100 Centimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Length: 100 Centimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Length: 100 Centimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Length: 100 Centimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• 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.
• 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	00613994781345 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062420

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: 2016-04-29

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• 00613994842381: CATHETER SA6AL15 SA 6F 100CM AL15
• 20613994842378: CATHETER SA6AL105 SA 6F 5PK 100CM AL10
• 20613994842248: CATHETER SA6AL205 SA 6F 5PK 100CM AL20
• 20613994842231: CATHETER SA6AR105 SA 6F 5PK 100CM AR10
• 20613994842224: CATHETER SA6AR205 SA 6F 5PK 100CM AR20
• 20613994842217: CATHETER SA6EBU355 SA 6F 5PK 100CM EB35
• 20613994842200: CATHETER SA6EBU405 SA 6F 5PK100CM EB40
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• 20613994842187: CATHETER SA6JL505 SA 6F 5PK 100CM JL50
• 00613994842176: CATHETER SA6JR60SH SA 6F 100CM JR60
• 00613994824837: CATHETER SA6ECR35SH SA 6F 100CM ECR35
• 00613994824820: CATHETER SA6ECR40 SA 6F 100CM ECR40
• 00613994824813: CATHETER SA6ECR40SH SA 6F 100CM ECR40
• 00613994824806: CATHETER SA6ECR45 SA 6F 100CM ECR45
• 00613994824790: CATHETER SA6ECR45SH SA 6F 100CM ECR45
• 00613994824783: CATHETER SA6ELGAMAL SA 6F 100CM EG
• 00613994824776: CATHETER SA6ELGAMALSH SA 6F 100CM EG
• 00613994824769: CATHETER SA6ERADL SA 6F 100CM ERDL
• 00613994824752: CATHETER SA6ERADLLT SA 6F 100CM ERDLL
• 00613994824745: CATHETER SA6ERADLLTSH SA 6F 100CM ERDLL
• 00613994824738: CATHETER SA6ERADLSH SA 6F 100CM ERDL
• 00613994824721: CATHETER SA6ERADLST SA 6F 100CM ERDLS
• 00613994824714: CATHETER SA6ERADLSTSH SA 6F 100CM ERDLS
• 00613994824707: CATHETER SA6ERADR SA 6F 100CM ERDR
• 00613994824691: CATHETER SA6ERADRSH SA 6F 100CM ERDR
• 00613994824684: CATHETER SA6ERADRST SA 6F 100CM ERDRS
• 00613994824677: CATHETER SA6ERADRSTSH SA 6F 100CM ERDRS
• 00613994824660: CATHETER SA6FL40 SA 6F 100CM FL40
• 00613994824653: CATHETER SA6FL40G SA 6F 100CM FL40G
• 00613994824646: CATHETER SA6FL40GSH SA 6F 100CM FL40G
• 00613994824639: CATHETER SA6EBU45 SA 6F 100CM EB45
• 00613994824622: CATHETER SA6EBU45A SA 6F 110CM EB45
• 00613994824615: CATHETER SA6EBU45SH SA 6F 100CM EB45
• 00613994824608: CATHETER SA6EBU50 SA 6F 100CM EB50
• 00613994824592: CATHETER SA6EBU50SH SA 6F 100CM EB50
• 00613994824585: CATHETER SA6EBUL30 SA 6F 100CM EL30
• 00613994824578: CATHETER SA6EBUL30SH SA 6F 100CM EL30
• 00613994824561: CATHETER SA6EBUL35 SA 6F 100CM EL35
• 00613994824554: CATHETER SA6EBUL35SH SA 6F 100CM EL35
• 00613994824547: CATHETER SA6EBUL375 SA 6F 100CM EL375
• 00613994824530: CATHETER SA6EBUL375SH SA 6F 100CM EL375
• 00613994824523: CATHETER SA6EBUL40 SA 6F 100CM EL40
• 00613994824516: CATHETER SA6EBUL40SH SA 6F 100CM EL40
• 00613994824509: CATHETER SA6EBUL45 SA 6F 100CM EL45
• 00613994824493: CATHETER SA6EBUL45SH SA 6F 100CM EL45
• 00613994824486: CATHETER SA6EBUL50 SA 6F 100CM EL50
• 00613994824479: CATHETER SA6EBUL50SH SA 6F 100CM EL50