SHERPA NX BALANCED

GUDID 00613994764690

CATHETER SB8MAC45 SB 8F 100CM MA45

MEDTRONIC, INC.

Vascular guide-catheter, single-use

• Primary Device ID: 00613994764690
• NIH Device Record Key: 87186a0c-df10-4cac-becb-a82ccb201410
• Commercial Distribution Discontinuation: 2017-08-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: SHERPA NX BALANCED
• Version Model Number: SB8MAC45
• 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

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

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	00613994764690 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060418

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: 2016-05-09

On-Brand Devices [SHERPA NX BALANCED]

• 00613994905314: CATHETER SB6PAPA1 SB 6F 100CM PAPA1
• 00613994905307: CATHETER SB6PAPA SB 6F 100CM PAPA
• 00613994846457: CATHETER SB7AR20A SB 7F 110CM AR20
• 20613994846444: CATHETER SB6JL505 SB 6F 5PK 100CM JL50
• 00613994842428: CATHETER SB7LCBA SB 7F 110CM LCB
• 00613994842411: CATHETER SB7JR40A SB 7F 110CM JR40
• 00613994842404: CATHETER SB7JL40A SB 7F 110CM JL40
• 00613994842398: CATHETER SB7AL20A SB 7F 110CM AL20
• 00613994837776: CATHETER SB7EBUL35 SB 7F 100CM EL35
• 00613994837769: CATHETER SB7EBUL35SH SB 7F 100CM EL35
• 00613994837752: CATHETER SB7EBUL375 SB 7F 100CM EL375
• 00613994837745: CATHETER SB7EBUL375SH SB 7F 100CM EL375
• 00613994837738: CATHETER SB7EBUL40 SB 7F 100CM EL40
• 00613994837721: CATHETER SB7EBUL40SH SB 7F 100CM EL40
• 00613994837714: CATHETER SB7EBUL45 SB 7F 100CM EL45
• 00613994837707: CATHETER SB7EBUL45SH SB 7F 100CM EL45
• 00613994837691: CATHETER SB7EBUL50 SB 7F 100CM EL50
• 00613994837684: CATHETER SB7EBUL50SH SB 7F 100CM EL50
• 00613994837677: CATHETER SB7ECR35 SB 7F 100CM ECR35
• 00613994837660: CATHETER SB7ECR35SH SB 7F 100CM ECR35
• 00613994837653: CATHETER SB7ECR40 SB 7F 100CM ECR40
• 00613994837646: CATHETER SB7ECR40SH SB 7F 100CM ECR40
• 00613994837639: CATHETER SB7ECR45 SB 7F 100CM ECR45
• 00613994837622: CATHETER SB7ECR45SH SB 7F 100CM ECR45
• 00613994837615: CATHETER SB7ELGAMAL SB 7F 100CM EG
• 00613994837608: CATHETER SB7EBUL30SH SB 7F 100CM EL30
• 00613994837592: CATHETER SB7EBU35 SB 7F 100CM EB35
• 20613994837589: CATHETER SB7EBU355 SB 7F 100CM 5PK EB35
• 00613994837578: CATHETER SB7EBU35SH SB 7F 100CM EB35
• 00613994837561: CATHETER SB7EBU35SHD SB 7F 90CM EB35
• 00613994837554: CATHETER SB7EBU375 SB 7F 100CM EB375
• 00613994837547: CATHETER SB7EBU375SH SB 7F 100CM EB375
• 00613994837530: CATHETER SB7EBU375SHD SB 7F 90CM EB375
• 00613994837523: CATHETER SB7EBU40 SB 7F 100CM EB40
• 20613994837510: CATHETER SB7EBU405 SB 7F 100CM 5PK EB40
• 00613994837509: CATHETER SB7EBU40D SB 7F 90CM EB40
• 00613994837493: CATHETER SB7EBU40SH SB 7F 100CM EB40
• 00613994837486: CATHETER SB7EBU45 SB 7F 100CM EB45
• 20613994837473: CATHETER SB7EBU455 SB 7F 100CM 5PK EB45
• 00613994837462: CATHETER SB7EBU45SH SB 7F 100CM EB45
• 00613994837455: CATHETER SB7EBU50 SB 7F 100CM EB50
• 00613994837448: CATHETER SB7EBU50SH SB 7F 100CM EB50
• 00613994837431: CATHETER SB7EBUL30 SB 7F 100CM EL30
• 00613994837424: CATHETER SB7IMT SB 7F 100CM IMT
• 00613994837417: CATHETER SB7JCL30 SB 7F 100CM JCL30
• 00613994837400: CATHETER SB7JCL30SH SB 7F 100CM JCL30
• 00613994837394: CATHETER SB7JCL35 SB 7F 100CM JCL35
• 00613994837387: CATHETER SB7JCL35SH SB 7F 100CM JCL35
• 00613994837370: CATHETER SB7JCL40 SB 7F 100CM JCL40
• 00613994837363: CATHETER SB7JCL40SH SB 7F 100CM JCL40