G3 X Apap

FDA UDI

Class II (US FDA UDI)

by Bmc Medical., Ltd.

Identity

Trade Name: G3 X APAP FDA UDI
Generic Name: Home CPAP unit FDA UDI
Device Name: G3 X APAP FDA UDI
Model / Reference: G46002 FDA UDI
Description: G3 X APAP FDA UDI

Identifiers

Primary DI / UDI-DI: 06948538363560 FDA UDI
FDA Product Code: BZD FDA UDI
GMDN Term: Home CPAP unit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5905 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

MRI Safety

MR Safe FDA UDI

Category: Home CPAP unit

G3 X Apap by Bmc Medical., Ltd. — 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: Bmc Medical., Ltd.

Sources (1)

FDA UDI dd202c49-2482-454b-ab78-c9aec36bddfe 33 fields · synced Jun 6, 2026