FDA.reportPublic FDA data

AIRFIT F30I

Primary DI
00619498633517
Brand
AIRFIT F30I
Company
RESMED LIMITED
Model
63351
Catalog number
63351
Device description
AIRFIT F30I CUSHION MED
Published
2020-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00619498633517PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00619498633517006194986335176194986335170619498633517

GMDN Terms#

Term, Definition table
TermDefinition
CPAP/BPAP face mask, single-useA non-sterile, flexible, form-shaped device designed to be placed over a user's nose and mouth to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic/silicone materials that create an airtight seal around the nose and mouth. It is available in various designs and sizes and stabilized with a headstrap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8004240737reception@resmed.com

Regulatory Flags#

DUNS number
751149311
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00619498390014AIR 1139001390012021-06-25
00619498390021AIR 1139002390022021-06-25
00619498390038AIR 1139003390032021-06-25
00619498390045AIR 1139004390042021-06-25
00619498390052AIR 1139005390052021-06-25
00619498393022AIR 1139302393022021-06-25
00619498393039AIR 1139303393032021-06-25
00619498393046AIR 1139304393042021-06-25
00619498393053AIR 1139305393052021-06-25
00619498393060AIR 1139306393062021-06-25
00619498393077AIR 1139307393072021-06-25
00619498629442AirFit P1062944629442021-05-06
00619498629459AirFit P1062945629452021-05-06
00619498394203AIR 1139300393002021-03-31
00619498391004HUMIDAIR11 STANDARD39100391002021-03-31
00619498003273CLIMATELINEAIR 1139102391022021-03-31
00619498392056AIR 1139205392052021-03-31
00619498392209AIR 1139220392202021-03-31
00619498393008AIR 1139300393002021-03-31
00619498393015AIR 1139301393012021-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09420012464699Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-19
04719893347258WellellWellell Inc.BZD2026-03-17
04719893347265WellellWellell Inc.BZD2026-03-17
04719893347272WellellWellell Inc.BZD2026-03-17
24710810084946N/AGALEMED CORPORATIONBZD2026-03-05
44710810089747N/AGALEMED CORPORATIONBZD2026-03-05
44710810115620N/AGALEMED CORPORATIONBZD2026-03-05
44710810115637N/AGALEMED CORPORATIONBZD2026-03-05
44710810109636N/AGALEMED CORPORATIONBZD2026-03-05
44710810109643N/AGALEMED CORPORATIONBZD2026-03-05
44710810109650N/AGALEMED CORPORATIONBZD2026-03-05
44710810119666N/AGALEMED CORPORATIONBZD2026-03-05
44710810110175N/AGALEMED CORPORATIONBZD2026-03-05
44710810112452N/AGALEMED CORPORATIONBZD2026-03-05
00814747024676Arie Nasal Vented Mask, SmallSLEEPNET, CORP.BZD2026-03-04
00814747024683Arie Nasal Vented Mask, MediumSLEEPNET, CORP.BZD2026-03-04
00814747024690Arie Nasal Vented Mask, LargeSLEEPNET, CORP.BZD2026-03-04
00814747024706Arie Nasal Vented Mask KitSLEEPNET, CORP.BZD2026-03-04
00814747024713Arie Full Face Vented Mask, SmallSLEEPNET, CORP.BZD2026-03-04
00814747024720Arie Full Face Vented Mask, MediumSLEEPNET, CORP.BZD2026-03-04
00814747024737Arie Full Face Vented Mask, LargeSLEEPNET, CORP.BZD2026-03-04
00814747024744Arie Full Face Vented Mask KitSLEEPNET, CORP.BZD2026-03-04
10848530108356Vented CPAP Masks SUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-03-03
10848530108363Vented CPAP Masks SUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-03-03
10848530108370Vented CPAP Masks SUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-03-03
10848530108387Vented CPAP Masks SUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-03-03
16948538340162Siesta Contour Nasal MaskBMC Medical Co., Ltd.BZD2026-02-02
16948538340179Siesta Contour Nasal MaskBMC Medical Co., Ltd.BZD2026-02-02
16948538340186Siesta Contour Nasal MaskBMC Medical Co., Ltd.BZD2026-02-02
16948538340193Siesta Contour Nasal MaskBMC Medical Co., Ltd.BZD2026-02-02