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Z-One

FDA UDI

Class II (US FDA UDI)

by Zamar Medical D.O.O.

Identity

Trade Name
Z-ONE FDA UDI
Generic Name
Circulating-fluid localized thermal/compression therapy system control unit FDA UDI
Model / Reference
MG455BC00E FDA UDI

Identifiers

Primary DI / UDI-DI
03858894530434 FDA UDI
510(k) Number
K242754 FDA UDI
FDA Product Code
IRP FDA UDI
ILO FDA UDI
GMDN Term
Circulating-fluid localized thermal/compression therapy system control unit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5650 FDA UDI
890.5720 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Circulating-fluid localized thermal/compression therapy system control unit

Z-One by Zamar Medical D.O.O. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Circulating-fluid localized thermal/compression therapy system control unit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Zamar Medical D.O.O.

Sources (1)

  • FDA UDI 7cc969ed-4f21-4e51-8db7-887ac184fe03 33 fields · synced May 30, 2026