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VersaPump Infuser

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref FP-0010209Model VersaPump Infusion System

by EMED Technologies Corporation

Identity

Trade Name
VersaPump Infuser EUDAMEDFDA UDI
Generic Name
Ambulatory non-insulin infusion pump, mechanical, reusable FDA UDI
Device Name
VersaPump Infuser EUDAMED
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). FDA UDI
Model / Reference
VersaPump Infusion System EUDAMED
FP-0010209 EUDAMEDFDA UDI
Description
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). FDA UDI

Identifiers

Catalog Number
FP-0010209 FDA UDI
Primary DI / UDI-DI
00817708023404 EUDAMEDFDA UDI
Basic UDI-DI
B-00817708023404 EUDAMED
510(k) Number
K230883 FDA UDI
FDA Product Code
PKP FDA UDI
EMDN Code
Z12030301 INFUSION PUMPS EUDAMED
GMDN Term
Ambulatory non-insulin infusion pump, mechanical, reusable FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
880.5725 FDA UDI
Market of Registration
France EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

Yes

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

VersaPump Infuser by EMED Technologies Corporation — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDD

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Manufacturer

Manufacturer
EMED Technologies Corporation
EUDAMED SRN
US-MF-000012148
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (3)

  • EUDAMED 8e8f3b38-fdf0-45c9-a1b7-54656d21f97f 61 fields · synced Jul 29, 2026
  • FDA UDI 110cb5b7-2e69-4555-9859-4667dff47898 37 fields · synced May 30, 2026
  • FDA 510(k) K230883 1 fields · synced May 18, 2026