FDA.reportPublic FDA data

Luna® G3 BPAP System

Primary DI
06948538365700
Brand
Luna® G3 BPAP System
Company
BMC Medical Co., Ltd.
Model
LG3800-25VT
Device description
Luna® G3 BPAP System
Published
2022-08-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
BZDVentilator, Non-Continuous (Respirator)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZDVentilator, Non-Continuous (Respirator)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06948538365700PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06948538365700069485383657006948538365700

GMDN Terms#

Term, Definition table
TermDefinition
Home BPAP unitA portable mains electricity (AC-powered) device, which may include rechargeable batteries, intended to assist noninvasive ventilation (i.e., without use of an artificial airway) using bi-level positive airway pressure (BPAP) during spontaneous respiration for adult/child (non-infant) patients affected by obstructive sleep apnoea (OSA) and/or to treat patients with conditions requiring respiratory assistance in the home [e.g., chronic obstructive pulmonary disease (COPD)]. It is a small desktop unit with controls, and may include a built-in humidifier. The device is intended for use in the home but may also be used in healthcare facilities.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
526010310
Device count
1
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06948538347683Alto Nasal Pillows InterfaceP6S (All Size Kit)2026-10-15
06948538347690Alto Nasal Pillows InterfaceP6S (Small)2026-10-15
06948538347706Alto Nasal Pillows InterfaceP6S (Medium)2026-10-15
06948538347713Alto Nasal Pillows InterfaceP6S(Large)2026-10-15
06948538347720Alto Nasal Pillows InterfaceP6S (All Size Kit)2026-10-15
06948538347737Alto Nasal Pillows InterfaceP6S(Small)2026-10-15
06948538347744Alto Nasal Pillows InterfaceP6S(Medium)2026-10-15
06948538347751Alto Nasal Pillows InterfaceP6S(Large)2026-10-15
06948538347768Alto Nasal Pillows InterfaceP6S (All Size Kit)2026-10-15
06948538347775Alto Nasal Pillows InterfaceP6S(Small)2026-10-15
06948538347782Alto Nasal Pillows InterfaceP6S(Medium)2026-10-15
06948538347799Alto Nasal Pillows InterfaceP6S(Large)2026-10-15
06948538347805Alto Nasal Pillows InterfaceP6S (All Size Kit)2026-10-15
06948538347812Alto Nasal Pillows InterfaceP6S (All Size Kit)2026-10-15
06948538347829Alto Nasal Pillows InterfaceP6S (All Size Kit)2026-10-15
06948538347836Alto Full Face MaskF6S (All Size Kit)2026-10-15
06948538347843Alto Full Face MaskF6S (Small)2026-10-15
06948538347850Alto Full Face MaskF6S (Medium)2026-10-15
06948538347867Alto Full Face MaskF6S(Large)2026-10-15
06948538347874Alto Full Face MaskF6S (All Size Kit)2026-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06948538347683Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347690Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347706Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347713Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347720Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347737Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347744Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347751Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347768Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347775Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347782Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347799Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347805Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347812Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347829Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347836Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347843Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347850Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347867Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347874Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347881Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347898Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347904Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347911Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347928Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347935Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347942Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347959Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347966Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347973Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15