NIPRO ELISIO™ -M HEMODIALYZER DD+ELISIO-13M

GUDID 40383790008493

Surface area 1.3m² Max.TMP:66kPa(500mmHg)

NIPRO MEDICAL CORPORATION

Hollow-fibre haemodialysis dialyser, single-use

• Primary Device ID: 40383790008493
• NIH Device Record Key: 13909199-daf7-4cd8-a7a7-cff971aadbde
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NIPRO ELISIO™ -M HEMODIALYZER
• Version Model Number: ELISIO™-13M
• Catalog Number: DD+ELISIO-13M
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00383790008495 [Primary]
GS1	40383790008493 [Package]; Contains: 00383790008495; Package: Case [24 Units]; In Commercial Distribution

FDA Product Code

• KDI: Dialyzer, high permeability with or without sealed dialysate system

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-09-16

On-Brand Devices [NIPRO ELISIO™ -M HEMODIALYZER]

• 40383790008530: Surface area 2.1m² Max.TMP:66kPa(500mmHg)
• 40383790008523: Surface area 1.9m² Max.TMP:66kPa(500mmHg)
• 40383790008516: Surface area 1.7m² Max.TMP:66kPa(500mmHg)
• 40383790008509: Surface area 1.5m² Max.TMP:66kPa(500mmHg)
• 40383790008493: Surface area 1.3m² Max.TMP:66kPa(500mmHg)
• 40383790008486: Surface area 1.1m² Max.TMP:66kPa(500mmHg)