Nipro SURDIAL DX Hemodialysis System

GUDID 00383790008815

Haemodialysis system, institutional

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

Device Issuing Agency	Device ID
GS1	00383790008815 [Primary]

KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System

Steralize Prior To Use	false
Device Is Sterile	false

40383790012377 - Blood pressure cuff for SURDIAL DX Hemodialysis System	2025-12-29 Blood pressure cuff - size small
40383790012384 - Blood pressure cuff for SURDIAL DX Hemodialysis System	2025-12-29 Blood pressure cuff - size medium
40383790012391 - Blood pressure cuff for SURDIAL DX Hemodialysis System	2025-12-29 Blood pressure cuff - size large
40383790012407 - Blood pressure cuff for SURDIAL DX Hemodialysis System	2025-12-29 Blood pressure cuff - size extra-large
40383790012414 - Blood pressure cuff hose for SURDIAL DX Hemodialysis System	2025-12-29 Blood pressure cuff hose
40383790011875 - SLIMLINE™ BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SET	2025-06-09 Slimline Blood Tubing for Fresenius 2008H, K, K2, T
40383790011882 - NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SET	2025-06-09 Blood Tubing Set for B Braun Dialog
40383790011899 - NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SET	2025-06-09 Blood Tubing Set for Fresenius 2008