KIDS

GUDID 38033178100350

SORIN GROUP ITALIA SRL

Extracorporeal membrane oxygenator

• Primary Device ID: 38033178100350
• NIH Device Record Key: 8bde1ecc-233e-45a4-aa2c-b943f3abe577
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KIDS
• Version Model Number: D100 PHISIO
• 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: 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	08033178100359 [Primary]
GS1	38033178100350 [Package]; Contains: 08033178100359; Package: BOX [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061031

FDA Product Code

• DTZ: OXYGENATOR, CARDIOPULMONARY BYPASS

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: 2020-01-22
• Device Publish Date: 2015-05-13

On-Brand Devices [KIDS]

• 38033178109797: D101 M PHISIO + SAMPLING LINE
• 38033178109780: D100 M PHISIO + SAMPLING LINE
• 38033178109612: D120 R PHISIO
• 38033178109308: D100 C PHISIO + SAMPLING LINE
• 38033178109292: D101 PHISIO
• 38033178100350: D100 PHISIO
• 38033178113473: D101 M
• 38033178113466: D100 M
• 38033178112865: D101
• 38033178112841: D100