PowerCube+ Series

FDA UDI

Class II (US FDA UDI)

by Ganshorn Medizin Electronic GmbH

Identity

Trade Name: PowerCube+ Series FDA UDI
Generic Name: Pulmonary function analysis system, adult FDA UDI
Device Name: The PowerCube Body+ include a wheelchair body plethysmography chamber with a door that opens to the right. FDA UDI
Model / Reference: A FDA UDI
Description: The PowerCube Body+ include a wheelchair body plethysmography chamber with a door that opens to the right. FDA UDI

Identifiers

Primary DI / UDI-DI: 07613365501216 FDA UDI
FDA Product Code: JEH FDA UDI
BZG FDA UDI
GMDN Term: Pulmonary function analysis system, adult FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.1760 FDA UDI
868.1840 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Pulmonary function analysis system, adult

PowerCube+ Series by Ganshorn Medizin Electronic GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Ganshorn Medizin Electronic GmbH

Sources (1)

FDA UDI 29dd12c1-576b-434f-8be6-3826a3a1b30c 33 fields · synced May 30, 2026