SH

GUDID 38033178233638

SORIN GROUP ITALIA SRL

Haemoconcentrator

• Primary Device ID: 38033178233638
• NIH Device Record Key: 22dc80f8-b714-4f47-946b-347d07e6f64b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SH
• Version Model Number: 14 - HEMOCONCENTRATOR
• Company DUNS: 442126587
• Company Name: SORIN GROUP ITALIA SRL
• 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: true
• 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	08033178233637 [Primary]
GS1	38033178233638 [Package]; Contains: 08033178233637; Package: BOX [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081313

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: 4
• Public Version Date: 2026-03-19
• Device Publish Date: 2015-07-15

Devices Manufactured by SORIN GROUP ITALIA SRL

• 38033178102934 - DHF: 2026-03-19
• 38033178102941 - DHF: 2026-03-19
• 38033178233638 - SH: 2026-03-19
• 38033178233638 - SH: 2026-03-19
• 38033178019621 - Aortic Root cannula: 2026-03-16
• 38033178019638 - Aortic Root cannula: 2026-03-16
• 38033178019645 - Vessel Cannula: 2026-03-16
• 38033178019652 - Vessel Cannula: 2026-03-16
• 38033178019669 - Vessel Cannula: 2026-03-16