FDA.reportPublic FDA data

Luna®

Primary DI
06948538362044
Brand
Luna®
Company
BMC Medical Co., Ltd.
Model
H60
Device description
Luna® Integrated Heated Humidifier
Published
2016-05-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
16948538362041PackageGS14In Commercial Distribution
06948538362044PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1694853836204116948538362041
06948538362044069485383620446948538362044

GMDN Terms#

Term, Definition table
TermDefinition
Heated respiratory humidifierA mains electricity (AC-powered) device designed to heat and humidify air/oxygen inspired by a patient to help maintain the mucous membranes of the respiratory tract typically during periods of prolonged respiratory support/therapy (e.g., mechanical ventilation, BPAP/CPAP therapy). The heated/humidified gases are delivered to the patient's airway and lungs via the nose/mouth or a tracheostoma in association with a parent respiratory device (e.g., ventilator, BPAP/CPAP unit). The humidifier typically includes a heating element and provisions for attaching a humidification chamber and tubing set.

Contacts#

Phone, Email table
PhoneEmail
+1-863-226-6285cpewitt@3Bproducts.com

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
00814747025017Arie Full Face Vented Mask KitSLEEPNET, CORP.BZD2026-10-23
00814747025024Arie Full Face Vented Mask, SmallSLEEPNET, CORP.BZD2026-10-23
00814747025031Arie Full Face Vented Mask, MediumSLEEPNET, CORP.BZD2026-10-23
00814747025048Arie Full Face Vented Mask, LargeSLEEPNET, CORP.BZD2026-10-23
00814747025055Ascend Full Face Vented Mask KitSLEEPNET, CORP.BZD2026-10-23
00814747025062Ascend Full Face Vented Mask, SmallSLEEPNET, CORP.BZD2026-10-23
00814747025079Ascend Full Face Vented Mask, MediumSLEEPNET, CORP.BZD2026-10-23
00814747025086Ascend Full Face Vented Mask, LargeSLEEPNET, CORP.BZD2026-10-23
00814747025093Arie Nasal Vented Mask KitSLEEPNET, CORP.BZD2026-10-23
00814747025109Arie Nasal Vented Mask, SmallSLEEPNET, CORP.BZD2026-10-23
00814747025116Arie Nasal Vented Mask, MediumSLEEPNET, CORP.BZD2026-10-23
00814747025123Arie Nasal Vented Mask, LargeSLEEPNET, CORP.BZD2026-10-23
00814747025130Ascend Nasal Vented Mask KitSLEEPNET, CORP.BZD2026-10-23
00814747025147Ascend Nasal Vented Mask, SmallSLEEPNET, CORP.BZD2026-10-23
00814747025154Ascend Nasal Vented Mask, SmallSLEEPNET, CORP.BZD2026-10-23
00814747025161Ascend Nasal Vented Mask, LargeSLEEPNET, CORP.BZD2026-10-23
00814747025178IQ 2 Nasal MaskSLEEPNET, CORP.BZD2026-10-23
00814747025185Phantom 2 Nasal Vented MaskSLEEPNET, CORP.BZD2026-10-23
00814747025192MiniMe 2 Pediatric Nasal Vented Mask, Extra SmallSLEEPNET, CORP.BZD2026-10-23
00814747025208MiniMe 2 Pediatric Nasal Vented Mask, SmallSLEEPNET, CORP.BZD2026-10-23
00814747025215MiniMe 2 Pediatric Nasal Vented Mask, MediumSLEEPNET, CORP.BZD2026-10-23
00814747025222MiniMe 2 Pediatric Nasal Vented Mask, LargeSLEEPNET, CORP.BZD2026-10-23
00814747025314Novaplus Full Face Vented Mask, Extra LargeSLEEPNET, CORP.BZD2026-10-23
00814747025321Novaplus Full Face Vented Mask, LargeSLEEPNET, CORP.BZD2026-10-23
00814747025338Novaplus Full Face Vented Mask, MediumSLEEPNET, CORP.BZD2026-10-23
00814747025345Novaplus Full Face Vented Mask, SmallSLEEPNET, CORP.BZD2026-10-23
00814747025352Novaplus Hospital Nasal Non Vented Mask, m/lSLEEPNET, CORP.BZD2026-10-23
00814747025369Novaplus Hospital Nasal Non Vented Mask, s/mSLEEPNET, CORP.BZD2026-10-23
00814747025376Novaplus Hospital Nasal Vented Mask, m/lSLEEPNET, CORP.BZD2026-10-23
00814747025383Novaplus Hospital Nasal Vented Mask, s/mSLEEPNET, CORP.BZD2026-10-23