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DioBreeze Cart

FDA UDI

Class I (US FDA UDI)

by Formatk Systems Ltd

Identity

Trade Name
DioBreeze Cart FDA UDI
Generic Name
Electromechanical device/system transport trolley FDA UDI
Device Name
Cart to be used with Formatk Systems Ltd Magma Spark, Magma Spark Pro, Magma Spark Plus, Alpha, DioBreeze (Desktop) featuring Mobile system FDA UDI
Model / Reference
FS80023 FDA UDI
Description
Cart to be used with Formatk Systems Ltd Magma Spark, Magma Spark Pro, Magma Spark Plus, Alpha, DioBreeze (Desktop) featuring Mobile system FDA UDI

Identifiers

Catalog Number
FS80023 FDA UDI
Primary DI / UDI-DI
07290016681130 FDA UDI
510(k) Number
K183307 FDA UDI
FDA Product Code
BZN FDA UDI
GMDN Term
Electromechanical device/system transport trolley FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
868.6175 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Electromechanical device/system transport trolley

DioBreeze Cart by Formatk Systems Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electromechanical device/system transport trolley.

Cleared under the same submission

K183307 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Formatk Systems Ltd

Sources (1)

  • FDA UDI f778c948-28d0-481e-b22b-bafcd765f672 35 fields · synced Jun 8, 2026