SHERPA NX BALANCED™

GUDID 00763000894610

CATHETER SB6MB1D SB 6F 90CM MB1

MEDTRONIC, INC.

Vascular guide-catheter, single-use

• Primary Device ID: 00763000894610
• NIH Device Record Key: b5909497-1217-4a68-8b7b-d8c7b6e1698e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SHERPA NX BALANCED™
• Version Model Number: SB6MB1D
• 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

Device Dimensions

• Catheter Length: 90 Centimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Length: 90 Centimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Length: 90 Centimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Length: 90 Centimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Length: 90 Centimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Length: 90 Centimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Length: 90 Centimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Length: 90 Centimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Length: 90 Centimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Length: 90 Centimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Length: 90 Centimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Length: 90 Centimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Length: 90 Centimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Length: 90 Centimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Length: 90 Centimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Length: 90 Centimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Length: 90 Centimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Length: 90 Centimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Length: 90 Centimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Length: 90 Centimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Length: 90 Centimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Length: 90 Centimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Length: 90 Centimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Length: 90 Centimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Length: 90 Centimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Length: 90 Centimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Length: 90 Centimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Length: 90 Centimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Length: 90 Centimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Length: 90 Centimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Length: 90 Centimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store the device at room temperature in a dry place. Keep the device away from sunlight or UV light.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store the device at room temperature in a dry place. Keep the device away from sunlight or UV light.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store the device at room temperature in a dry place. Keep the device away from sunlight or UV light.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store the device at room temperature in a dry place. Keep the device away from sunlight or UV light.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store the device at room temperature in a dry place. Keep the device away from sunlight or UV light.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store the device at room temperature in a dry place. Keep the device away from sunlight or UV light.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store the device at room temperature in a dry place. Keep the device away from sunlight or UV light.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store the device at room temperature in a dry place. Keep the device away from sunlight or UV light.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store the device at room temperature in a dry place. Keep the device away from sunlight or UV light.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store the device at room temperature in a dry place. Keep the device away from sunlight or UV light.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store the device at room temperature in a dry place. Keep the device away from sunlight or UV light.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store the device at room temperature in a dry place. Keep the device away from sunlight or UV light.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store the device at room temperature in a dry place. Keep the device away from sunlight or UV light.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store the device at room temperature in a dry place. Keep the device away from sunlight or UV light.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store the device at room temperature in a dry place. Keep the device away from sunlight or UV light.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store the device at room temperature in a dry place. Keep the device away from sunlight or UV light.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store the device at room temperature in a dry place. Keep the device away from sunlight or UV light.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store the device at room temperature in a dry place. Keep the device away from sunlight or UV light.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store the device at room temperature in a dry place. Keep the device away from sunlight or UV light.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store the device at room temperature in a dry place. Keep the device away from sunlight or UV light.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store the device at room temperature in a dry place. Keep the device away from sunlight or UV light.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store the device at room temperature in a dry place. Keep the device away from sunlight or UV light.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store the device at room temperature in a dry place. Keep the device away from sunlight or UV light.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store the device at room temperature in a dry place. Keep the device away from sunlight or UV light.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store the device at room temperature in a dry place. Keep the device away from sunlight or UV light.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store the device at room temperature in a dry place. Keep the device away from sunlight or UV light.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store the device at room temperature in a dry place. Keep the device away from sunlight or UV light.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store the device at room temperature in a dry place. Keep the device away from sunlight or UV light.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store the device at room temperature in a dry place. Keep the device away from sunlight or UV light.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store the device at room temperature in a dry place. Keep the device away from sunlight or UV light.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store the device at room temperature in a dry place. Keep the device away from sunlight or UV light.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000894610 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232190

FDA Product Code

• DQY: Catheter, percutaneous

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: 2024-04-02
• Device Publish Date: 2024-03-25

On-Brand Devices [SHERPA NX BALANCED™]

• 00763000896447: CATHETER SB7SL40SH SB 7F 100CM SL40
• 00763000896430: CATHETER SB7SL40 SB 7F 100CM SL40
• 00763000896423: CATHETER SB7SL35SH SB 7F 100CM SL35
• 00763000896416: CATHETER SB7SL35 SB 7F 100CM SL35
• 00763000896409: CATHETER SB7SCR40SH SB 7F 100CM SCR40
• 00763000896393: CATHETER SB7SCR40 SB 7F 100CM SCR40
• 00763000896386: CATHETER SB7SCR35SH SB 7F 100CM SCR35
• 00763000896379: CATHETER SB7SAR20 SB 7F 100CM SAR20
• 00763000896362: CATHETER SB7SAR10 SB 7F 100CM SAR10
• 00763000896355: CATHETER SB7SAL75SH SB 7F 100CM SAL75
• 00763000896348: CATHETER SB7SAL75 SB 7F 100CM SAL75
• 00763000896331: CATHETER SB7SAL30 SB 7F 100CM SAL30
• 00763000896324: CATHETER SB7SAL20 SB 7F 100CM SAL20
• 00763000896317: CATHETER SB7SAL10SH SB 7F 100CM SAL10
• 00763000896300: CATHETER SB7SAL10 SB 7F 100CM SAL10
• 00763000896294: CATHETER SB7RCBSH SB 7F 100CM RCB
• 00763000896287: CATHETER SB7RCB SB 7F 100CM RCB
• 00763000896270: CATHETER SB7RBU45 SB 7F 100CM RB45
• 00763000896263: CATHETER SB7RBU40SH SB 7F 100CM RB40
• 00763000896256: CATHETER SB7RBU40 SB 7F 100CM RB40
• 00763000896249: CATHETER SB7RBU35SH SB 7F 100CM RB35
• 00763000896232: CATHETER SB7RBU35 SB 7F 100CM RB35
• 00763000896225: CATHETER SB7NOTO SB 7F 100CM NOTO
• 00763000896218: CATHETER SB7MRADIAL SB 7F 100CM MRAD
• 00763000896201: CATHETER SB7MP1SH SB 7F 100CM MP1
• 00763000896195: CATHETER SB7MP1 SB 7F 100CM MP1
• 00763000896188: CATHETER SB7MB2 SB 7F 100CM MB2
• 00763000896171: CATHETER SB7MB1SH SB 7F 100CM MB1
• 00763000896164: CATHETER SB7MB1 SB 7F 100CM MB1
• 00763000896157: CATHETER SB7MAC40SH SB 7F 100CM MA40
• 00763000896140: CATHETER SB7MAC40 SB 7F 100CM MA40
• 00763000896133: CATHETER SB7MAC35SH SB 7F 100CM MA35
• 00763000896126: CATHETER SB7MAC35 SB 7F 100CM MA35
• 00763000896119: CATHETER SB7MAC30SH SB 7F 100CM MA30
• 00763000896102: CATHETER SB7MAC30 SB 7F 100CM MA30
• 00763000896096: CATHETER SB7LCBSH SB 7F 100CM LCB
• 00763000896089: CATHETER SB7LCB SB 7F 100CM LCB
• 00763000896072: CATHETER SB7JR60 SB 7F 100CM JR60
• 00763000896065: CATHETER SB7JR50SH SB 7F 100CM JR50
• 00763000896058: CATHETER SB7JR50 SB 7F 100CM JR50
• 00763000896041: CATHETER SB7JR45SH SB 7F 100CM JR45
• 00763000896034: CATHETER SB7JR45 SB 7F 100CM JR45
• 00763000896027: CATHETER SB7JR40SH SB 7F 100CM JR40
• 00763000896010: CATHETER SB7JR40D SB 7F 90CM JR40
• 00763000896003: CATHETER SB7JR40 SB 7F 100CM JR40
• 00763000895990: CATHETER SB7JR35SH SB 7F 100CM JR35
• 00763000895983: CATHETER SB7JR35 SB 7F 100CM JR35
• 00763000895976: CATHETER SB7JR30 SB 7F 100CM JR30
• 00763000895969: CATHETER SB7JL60SH SB 7F 100CM JL60
• 00763000895952: CATHETER SB7JL60 SB 7F 100CM JL60