DOUBLEFO 72205360

GUDID 03661379196007

SMITH + NEPHEW PUMP/SHAVER INTERFACE CABLE

HEMODIA

Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable

• Primary Device ID: 03661379196007
• NIH Device Record Key: 60a9200d-9395-4f6b-9d6d-82ea8f82bf8c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DOUBLEFO
• Version Model Number: A
• Catalog Number: 72205360
• Company DUNS: 381957786
• Company Name: HEMODIA
• 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: true
• Serial Number: false
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	03661379196007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203480

FDA Product Code

• HRX: Arthroscope

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: 2021-04-21
• Device Publish Date: 2021-04-13

Devices Manufactured by HEMODIA

• 03661379239056 - DOUBLEFLO: 2023-10-09 DOUBLEFLO INFLOW/OUTFLOW PUMP - Retrofit
• 03661379196014 - DOUBLEFLO: 2023-03-30 HAND CONTROL INTERFACE ARTX
• 03661379196021 - DOUBLEFLO: 2023-03-30 FOOT CONTROL INTERFACE ARTX
• 03661379196038 - DOUBLEFLO: 2023-03-30 HAND CONTROL INTERFACE SYK
• 03661379196045 - DOUBLEFLO: 2023-03-30 HAND CONTROL INTERFACE CMD
• 03661379196052 - DOUBLEFLO: 2023-03-30 FOOT CONTROL INTERFACE CMD
• 03661379196076 - DOUBLEFLO: 2023-03-30 POWER CORD FOR UK/SAUDI ARABIA
• 03661379196083 - DOUBLEFLO: 2023-03-30 POWER CORD FOR EU