SimplFusor

GUDID 28859299117908

SimplFusor C300-6-50h

EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED

Elastomeric infusion pump system

• Primary Device ID: 28859299117908
• NIH Device Record Key: b18c8bb5-43b0-410c-8270-5fc5b2b6922e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SimplFusor
• Version Model Number: 484252BAX
• Company DUNS: 662213220
• Company Name: EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED
• 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	18859299117901 [Primary]
GS1	28859299117908 [Package]; Contains: 18859299117901; Package: Carton [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151650

FDA Product Code

• MEB: Pump, Infusion, Elastomeric

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: 2024-06-10
• Device Publish Date: 2024-05-31

On-Brand Devices [SimplFusor]

• 98859299118089: SimplFusor 50-50-60m
• 98859299117730: SimplFusor 250-175-90m
• 98859299117716: SimplFusor 250-250-60m
• 98859299117693: SimplFusor 100-100-60m
• 98859299117655: SimplFusor 100-200-30m
• 98859299117525: SimplFusor 270-10-27h
• 28859299117908: SimplFusor C300-6-50h
• 28859299117892: SimplFusor C270-10-27h
• 28859299117885: SimplFusor C270-5-54h
• 28859299117878: SimplFusor C120-4-30h
• 28859299117861: SimplFusor C270-2-135h
• 28859299117854: SimplFusor C100-2-50h
• 28859299117847: SimplFusor 200-100-120m
• 28859299117830: SimplFusor 270-175-90m
• 28859299117823: SimplFusor 500-20-25h
• 28859299117816: SimplFusor 250-50-300m
• 28859299117809: SimplFusor 200-200-60m
• 28859299117793: SimplFusor 250-125-120m
• 28859299117786: SimplFusor 250-100-150m
• 28859299117779: SimplFusor 400-100-240m
• 28859299117762: SimplFusor 100-50-120m
• 28859299117755: SimplFusor 500-250-120m
• 28859299117748: SimplFusor 400-200-120m
• 28859299117724: SimplFusor 250-175-90m
• 28859299117700: SimplFusor 250-250-60m
• 28859299117687: SimplFusor 100-100-60m
• 28859299117670: SimplFusor 50-50-60m
• 28859299117663: SimplFusor 250-500-30m
• 28859299117649: SimplFusor 100-200-30m
• 28859299117632: SimplFusor 100-5-20h
• 28859299117625: SimplFusor 100-0.5-200h
• 28859299117618: SimplFusor 270-2-135h
• 28859299117601: SimplFusor 400-4-100h
• 28859299117595: SimplFusor 270-4-68h
• 28859299117588: SimplFusor 400-5-80h
• 28859299117571: SimplFusor 270-5-54h
• 28859299117564: SimplFusor 100-2-50h
• 28859299117557: SimplFusor 400-10-40h
• 28859299117540: SimplFusor 120-4-30h
• 28859299117533: SimplFusor 60-2-30h
• 28859299117519: SimplFusor 270-10-27h
• 28859299117502: SimplFusor 125-5-25h
• 28859299117496: SimplFusor 60-5-12h