FixPad Anchoring Device

GUDID 04711182607982

FORTUNE MEDICAL INSTRUMENT CORP.

Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder

• Primary Device ID: 04711182607982
• NIH Device Record Key: 73f4b13d-a863-4ca3-9649-c4e79fe8312b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FixPad Anchoring Device
• Version Model Number: 1800-0005
• Company DUNS: 656763489
• Company Name: FORTUNE MEDICAL INSTRUMENT CORP.
• Device Count: 30
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04711182607982 [Unit of Use]
GS1	14711182607989 [Primary]

FDA Product Code

• MZR: Topical Approximation System

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: 2021-11-23
• Device Publish Date: 2021-11-15

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• 04710961934851 - Silicone C.W.V. Reservoir: 2022-02-08
• 04710961934868 - Silicone C.W.V. Reservoir: 2022-02-08
• 04710961934875 - Silicone C.W.V. Reservoir (Top Outlet): 2022-02-08
• 04710961934882 - Silicone C.W.V. Reservoir: 2022-02-08