DOUBLEFLO 72205354

GUDID 23661379195509

DOUBLEFLO PATIENT TUBE SET

HEMODIA

Surgical irrigation/aspiration tubing set

• Primary Device ID: 23661379195509
• NIH Device Record Key: 48ce1fff-d61c-41c2-9fe5-a85cc6b51982
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DOUBLEFLO
• Version Model Number: A
• Catalog Number: 72205354
• Company DUNS: 381957786
• Company Name: HEMODIA
• Device Count: 40
• 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	03661379195505 [Primary]
GS1	23661379195509 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203480

FDA Product Code

• HRX: Arthroscope

Sterilization

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

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

On-Brand Devices [DOUBLEFLO]

• 03661379196069: POWER CORD FOR US/CAN
• 03661379195987: DoubleFlo INFLOW/OUTFLOW PUMP AND MANUAL
• 23661379195530: DOUBLEFLO OUTFLOW TUBE SET
• 23661379195523: DOUBLEFLO INFLOW TUBE SET
• 23661379195509: DOUBLEFLO PATIENT TUBE SET
• 23661379195493: DOUBLEFLO DAY TUBE SET
• 03661379200414: FOOTSWITCH - WIRED
• 03661379195994: REMOTE
• 03661379211748: DOUBLEFLO INFLOW/OUTFLOW PUMP
• 03661379223086: DOUBLEFLO OUTFLOW TUBE SET
• 03661379223079: DOUBLEFLO INFLOW TUBE SET
• 03661379223062: DOUBLEFLO PATIENT TUBE SET
• 23661379223059: DOUBLEFLO DAY TUBE SET
• 03661379196113: POWER CORD FOR SWITZERLAND
• 03661379196090: POWER CORD FOR AUSTRALIA/NEW ZEALAND
• 03661379196083: POWER CORD FOR EU
• 03661379196076: POWER CORD FOR UK/SAUDI ARABIA
• 03661379196052: FOOT CONTROL INTERFACE CMD
• 03661379196045: HAND CONTROL INTERFACE CMD
• 03661379196038: HAND CONTROL INTERFACE SYK
• 03661379196021: FOOT CONTROL INTERFACE ARTX
• 03661379196014: HAND CONTROL INTERFACE ARTX
• 03661379239056: DOUBLEFLO INFLOW/OUTFLOW PUMP - Retrofit