VersaPump Infuser FP-0010209

GUDID 00817708023404

The VersaPump Infuser is a reusable mechanical, non-electronic infusion pump that does not require batteries or any electrical source. There are no alarms or displays. The VersaPump Infuser uses a spring as a source of energy to provide pressure for the subcutaneous infusion of the indicated human plasma-derived immunoglobulin solutions. The VersaPump Infuser is provided with a carrying case and User Manual. The carrying case allows the user to strap the VersaPump to their shoulder and walk around their environment during an infusion cycle. The VersaPump enclosure is made of synthetic polymer blend of glass reinforced polyphenylene ether and polystyrene, the spring is a 301 stainless steel spring, and the spring enclosure is made of synthetic polymer polyoxymethylene (POM/acetal).

EMED TECHNOLOGIES CORPORATION

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• Primary Device ID: 00817708023404
• NIH Device Record Key: 110cb5b7-2e69-4555-9859-4667dff47898
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VersaPump Infuser
• Version Model Number: FP-0010209
• Catalog Number: FP-0010209
• Company DUNS: 622637544
• Company Name: EMED TECHNOLOGIES CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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

Customer Support Contacts

• Phone: 916-932-0071
• Email: customerservice@emedtc.com
• Phone: 916-932-0071
• Email: customerservice@emedtc.com
• Phone: 916-932-0071
• Email: customerservice@emedtc.com
• Phone: 916-932-0071
• Email: customerservice@emedtc.com
• Phone: 916-932-0071
• Email: customerservice@emedtc.com
• Phone: 916-932-0071
• Email: customerservice@emedtc.com
• Phone: 916-932-0071
• Email: customerservice@emedtc.com
• Phone: 916-932-0071
• Email: customerservice@emedtc.com
• Phone: 916-932-0071
• Email: customerservice@emedtc.com
• Phone: 916-932-0071
• Email: customerservice@emedtc.com
• Phone: 916-932-0071
• Email: customerservice@emedtc.com
• Phone: 916-932-0071
• Email: customerservice@emedtc.com
• Phone: 916-932-0071
• Email: customerservice@emedtc.com
• Phone: 916-932-0071
• Email: customerservice@emedtc.com
• Phone: 916-932-0071
• Email: customerservice@emedtc.com
• Phone: 916-932-0071
• Email: customerservice@emedtc.com
• Phone: 916-932-0071
• Email: customerservice@emedtc.com

Operating and Storage Conditions

• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817708023404 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230883

FDA Product Code

• PKP: Immunoglobulin G (Igg) Infusion 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: 2023-12-26
• Device Publish Date: 2023-12-18

Devices Manufactured by EMED TECHNOLOGIES CORPORATION

• 00817708023404 - VersaPump Infuser: 2023-12-26The VersaPump Infuser is a reusable mechanical, non-electronic infusion pump that does not require batteries or any electrical source. There are no alarms or displays. The VersaPump Infuser uses a spring as a source of energy to provide pressure for the subcutaneous infusion of the indicated human plasma-derived immunoglobulin solutions. The VersaPump Infuser is provided with a carrying case and User Manual. The carrying case allows the user to strap the VersaPump to their shoulder and walk around their environment during an infusion cycle. The VersaPump enclosure is made of synthetic polymer blend of glass reinforced polyphenylene ether and polystyrene, the spring is a 301 stainless steel spring, and the spring enclosure is made of synthetic polymer polyoxymethylene (POM/acetal).
• 00817708023404 - VersaPump Infuser: 2023-12-26 The VersaPump Infuser is a reusable mechanical, non-electronic infusion pump that does not require batteries or any electrical s
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