FDA.reportPublic FDA data

Mobi Shoulder Bag

Primary DI
00619498350513
Brand
Mobi Shoulder Bag
Company
RESMED LIMITED
Model
35051
Catalog number
35051
Device description
Mobi Shoulder Bag
Published
2018-05-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
CAWGenerator, Oxygen, Portable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAWGenerator, Oxygen, PortableAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00619498350513PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00619498350513006194983505136194983505130619498350513

GMDN Terms#

Term, Definition table
TermDefinition
Stationary oxygen concentratorA stationary mains electricity (AC-powered) device designed to concentrate oxygen (O2) from ambient air and deliver the concentrated O2, typically through an attached nasal cannula, to a patient requiring oxygen therapy. It processes the air through an internal filtration system, e.g., a molecular sieve (zeolite granules or membranes), having a large total surface area to separate nitrogen (N2) from the air. It typically consists of an air compressor, filters, dual chambers, a reservoir and controls. The O2 concentration is variable depending on the flow rate utilized. It is typically wheeled but is designed to be placed in one location, e.g., an institution or a home setting.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal101 KiloPascal
Storage Environment Humidity15 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

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
false
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
10810178884459ViveBreatheVIVE HEALTH LLCCAW2026-01-30
00810178884469ViveBreatheVIVE HEALTH LLCCAW2026-01-30
00810178885190ViveBreatheVIVE HEALTH LLCCAW2026-01-30
00092237627495Roscoe MedicalCOMPASS HEALTH BRANDS CORP.CAW2026-01-15
06971882890314Rhythm HealthcareQingdao Kingon Medical Science and Technology Co., LtdCAW2026-01-07
06971882891328Rhythm HealthcareQingdao Kingon Medical Science and Technology Co., LtdCAW2026-01-07
06934726614347LongfianLongfian Scitech Co., Ltd.CAW2025-12-10
06934726614446Phoenix Pulse POCLongfian Scitech Co., Ltd.CAW2025-12-09
06972855530329Portable Oxygen ConcentratorJiangsu Jumao X-Care Medical Equipment Co.,LtdCAW2025-11-28
00860014866548Rhythm Healthcare, LLCRhythm Healthcare, LLCCAW2025-11-12
06977388230012WeOxyWeoxy Co., LTD.CAW2025-09-25
06977388230029WeOxyWeoxy Co., LTD.CAW2025-09-25
06977388230036WeOxyWeoxy Co., LTD.CAW2025-09-25
06978651650070RHYTHM HEALTHCARERhythm Healthcare, LLCCAW2025-09-01
M766AS2001410CAIRE Inc.CAIRE INC.CAW2025-08-13
M766AS2001460AryaCAIRE INC.CAW2025-08-13
M766AS2002410CAIRE Inc.CAIRE INC.CAW2025-08-13
M766AS2002460AryaCAIRE INC.CAW2025-08-13
M766AS200410CAIRE Inc.CAIRE INC.CAW2025-08-13
M766AS200460AryaCAIRE INC.CAW2025-08-13
M766AS200SW410CAIRE Inc.CAIRE INC.CAW2025-08-13
M766SCE1000NANB0HOMESTYLE AspenCAIRE INC.CAW2025-06-30
00817131020698OxyGo Fit+ Rove 4 Inogen, Inc.CAW2025-06-12
00817131020704Oxygo Next Rove 6 Inogen, Inc.CAW2025-06-11
06933257935419InogenJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.CAW2025-06-11
06933257924925YUWELL Portable Oxygen ConcentratorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.CAW2025-06-10
00840117342736Resp-O2 10L Oxygen Concentrator Dynarex CorporationCAW2025-06-03
00817698020698Healthcare Logistics SystemsHEALTHCARE LOGISTICS SYSTEMS LLCCAW2025-05-01
00885304033219DeVilbissDEVILBISS HEALTHCARE LLCCAW2025-04-28
00885304033226DeVilbissDEVILBISS HEALTHCARE LLCCAW2025-04-28