Nipro SURDIAL DX Hemodialysis System

GUDID 00383790008815

Hemodialysis System

NIPRO MEDICAL CORPORATION

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• Primary Device ID: 00383790008815
• NIH Device Record Key: 6d4daeb9-bba3-460c-ba14-39cb6e130fbb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nipro SURDIAL DX Hemodialysis System
• Version Model Number: MC+SDX01
• Company DUNS: 797372554
• Company Name: NIPRO MEDICAL CORPORATION
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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: 9083937030
• Email: info@nipromed.com
• Phone: 9083937030
• Email: info@nipromed.com
• Phone: 9083937030
• Email: info@nipromed.com
• Phone: 9083937030
• Email: info@nipromed.com
• Phone: 9083937030
• Email: info@nipromed.com
• Phone: 9083937030
• Email: info@nipromed.com
• Phone: 9083937030
• Email: info@nipromed.com
• Phone: 9083937030
• Email: info@nipromed.com
• Phone: 9083937030
• Email: info@nipromed.com
• Phone: 9083937030
• Email: info@nipromed.com
• Phone: 9083937030
• Email: info@nipromed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00383790008815 [Primary]

FDA Product Code

• KDI: Dialyzer, High Permeability With Or Without Sealed Dialysate System

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-07
• Device Publish Date: 2020-08-28

Devices Manufactured by NIPRO MEDICAL CORPORATION

• 10383790000304 - Nipro SafeTouch TULIP Safety Fistula Needle: 2023-09-25 SafeTouch Tulip Safety AVF (14Gx1") 12" tube, fixed hub
• 00383790000345 - Nipro SafeTouch TULIP Safety Fistula Needle: 2023-09-25 SafeTouch Tulip Safety AVF (14Gx1") 12" tube, fixed hub (twin pack)
• 10383790000366 - Nipro SafeTouch TULIP Safety Fistula Needle: 2023-09-25 SafeTouch Tulip Safety AVF (15Gx1") 12" tube, fixed hub
• 10383790000373 - Nipro SafeTouch TULIP Safety Fistula Needle: 2023-09-25 SafeTouch Tulip Safety AVF (15Gx1") 12" tube, rotating hub
• 10383790000380 - Nipro SafeTouch TULIP Safety Fistula Needle: 2023-09-25 SafeTouch Tulip Safety AVF (15Gx1-1/4") 12" tube, fixed hub
• 10383790000397 - Nipro SafeTouch TULIP Safety Fistula Needle: 2023-09-25 SafeTouch Tulip Safety AVF (15Gx1-1/4") 12" tube, rotating hub
• 00383790000406 - Nipro SafeTouch TULIP Safety Fistula Needle: 2023-09-25 SafeTouch Tulip Safety AVF (15Gx1") 12" tube, fixed hub (twin pack)
• 10383790000427 - Nipro SafeTouch TULIP Safety Fistula Needle: 2023-09-25 SafeTouch Tulip Safety AVF (16Gx1") 12" tube, fixed hub