gudid
Primary ID: FP-0010209
VersaPump Infuser (UDI FP-0010209)
Manufactured by EMED TECHNOLOGIES CORPORATION
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for VersaPump Infuser - Primary ID FP-0010209
Device Regulatory Overview
The VersaPump Infuser (Model/Catalog Number: FP-0010209) is a medical device manufactured by EMED TECHNOLOGIES CORPORATION. This product is indexed under FDA Product Code / Category Classification PKP within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- FP-0010209
- Product Code / EMDN
- PKP
- Device Name
- 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).
- Database Sync Date
- 2026-08-09 09:32:58
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of VersaPump Infuser?
The registered manufacturer of record for VersaPump Infuser is EMED TECHNOLOGIES CORPORATION.
What is the Primary UDI-DI identifier for VersaPump Infuser?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is FP-0010209.
What classification code is assigned to this device?
This device is registered under product classification code PKP.
Similar Classification Devices (PKP)
Other Devices by EMED TECHNOLOGIES CORPORATION
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