FDA.reportPublic FDA data

Invacare® SOLO2™ Transportable Oxygen Concentrator

Primary DI
00841447100102
Brand
Invacare® SOLO2™ Transportable Oxygen Concentrator
Company
INVACARE CORPORATION
Model
TPO100B
Catalog number
TPO100B
Published
2015-09-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
00841447100102PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841447100102008414471001028414471001020841447100102

GMDN Terms#

Term, Definition table
TermDefinition
Portable oxygen concentratorA portable 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 used in a home, institution, or a vehicle and typically has internal batteries for transportable use.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-2 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
440-329-6000orders@invacare.com

Regulatory Flags#

DUNS number
076916246
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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
00841447109754Invacare® Think Soft® Long Term Care Bed Positioning DeviceIHCSTSPD-QSPIHCSTSPD-QSP2026-03-02
00841447116301Easy Glide Wheelchair for InvacareEGWC16STRSBUEGWC16STRSBU2026-02-13
00841447116318Easy Glide Wheelchair for InvacareEGWC16STRSBKEGWC16STRSBK2026-02-13
00841447116325Easy Glide Wheelchair for InvacareEGWC16STREBUEGWC16STREBU2026-02-13
00841447116332Easy Glide Wheelchair for InvacareEGWC16STREBKEGWC16STREBK2026-02-13
00841447116349Easy Glide Wheelchair for InvacareEGWC18STRSBUEGWC18STRSBU2026-02-13
00841447116356Easy Glide Wheelchair for InvacareEGWC18STRSBKEGWC18STRSBK2026-02-13
00841447116363Easy Glide Wheelchair for InvacareEGWC18STREBKEGWC18STREBK2026-02-13
00841447116370Easy Glide Wheelchair for InvacareEGWC18STREBUEGWC18STREBU2026-02-13
00841447116387Easy Glide Wheelchair for InvacareEGWC20STRSBUEGWC20STRSBU2026-02-13
00841447116394Easy Glide Wheelchair for InvacareEGWC20STRSBKEGWC20STRSBK2026-02-13
00841447116400Easy Glide Wheelchair for InvacareEGWC20STREBUEGWC20STREBU2026-02-13
00841447116417Easy Glide Wheelchair for InvacareEGWC20STREBKEGWC20STREBK2026-02-13
00841447116424The Aftermarket Group (TAG) Schwalbe Right Run Wheelchair TireTAGSCHRR26TAGSCHRR262026-02-05
00841447116295Invacare® Bed Extender HeadspringG41G412025-12-05
00841447115144Invacare Solace Mattress CoverSPS1180CSPS1180C2025-06-30
00841447115151Invacare Solace MattressSPS1184SPS11842025-06-30
00841447115168Invacare Solace Mattress CoverSPS1184CSPS1184C2025-06-30
00841447115137Invacare Solace MattressSPS1180SPS11802025-06-23
00841447114680Invacare Essentials EX1IEX166DASAIEX166DASA2024-09-15

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Primary DI, Brand, Company table
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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
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00860014866548Rhythm Healthcare, LLCRhythm Healthcare, LLCCAW2025-11-12
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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
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