FDA.reportPublic FDA data

Healthcare Logistics Systems

Primary DI
00817698020698
Brand
Healthcare Logistics Systems
Company
HEALTHCARE LOGISTICS SYSTEMS LLC
Model
8050
Published
2025-05-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
CAWGenerator, Oxygen, Portable

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202389000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202389000Oxygen ConcentratorFoshan Mic Medical Technology Co., Ltd.2022-04-08CAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817698020698PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817698020698008176980206988176980206980817698020698

GMDN Terms#

Term, Definition table
TermDefinition
Mobile/portable oxygen concentratorA mobile/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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079452927
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817698020032Virtuox13002016-12-07
00817698020728HLS13002026-01-06
00817698020704Healthcare Logistics Systems15502025-05-01
00817698020711Healthcare Logistics Systems12502025-05-01
10817698020275Virtuox18502016-12-07
10817698020282Virtuox18512016-12-07
10817698020299Virtuox18532016-12-07
10817698020305Virtuox18522016-12-07
00817698020681Healthcare Logiix SystemsDream2024-05-01
10817698020190Virtuox18002016-12-07
10817698020206Virtuox18012016-12-07
10817698020213Virtuox18022016-12-07
10817698020220Virtuox18032016-12-07
10817698020237Virtuox12042016-12-07
10817698020244Virtuox12052016-12-07
10817698020251Virtuox12062016-12-07
10817698020268Virtuox12072016-12-07
10817698020312Virtuox19002016-12-07
10817698020329Virtuox19502016-12-07
90817698020592VirtuoxSPo2T2021-01-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810178889624Vive BreatheVIVE HEALTH LLCCAW2026-06-01
00885304034834DeVilbissDEVILBISS HEALTHCARE LLCCAW2026-05-12
00885304034841DeVilbissDEVILBISS HEALTHCARE LLCCAW2026-05-12
00885304034858DeVilbissDEVILBISS HEALTHCARE LLCCAW2026-05-12
00860007698262MOSTPacific Consolidated Industries LLCCAW2026-05-06
06934726614316LongfianLongfian Scitech Co., Ltd.CAW2026-05-04
00810178885756ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885763ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885770ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885787ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885794ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885800ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885817ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885824ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00850083102944Rhythm Healthcare, LLCRhythm Healthcare, LLCCAW2026-04-24
00850083102319Rhythm HealthcareRhythm Healthcare, LLCCAW2026-04-22
15060031380191RUGGED OXYGEN GENERATOR (ROG)MOLECULAR PRODUCTS LIMITEDCAW2026-04-21
06933257948488YUWELL Portable Oxygen ConcentratorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.CAW2026-02-24
00810178884452ViveBreatheVIVE HEALTH LLCCAW2026-01-30
00850018761451Internal Battery PM Upgrade USB DriveVentec Life Systems, Inc.CAW2025-12-02
M766AS200SW460AryaCAIRE INC.CAW2025-08-13
00850018761413Internal Battery PM Upgrade USB DriveVentec Life Systems, Inc.CAW2025-08-06
06933257921856YUWELL Oxygen ConcentratorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.CAW2024-01-09
10840330700396ProcureTwin Med, LLCCAW2022-11-03
M766AS200SW6AryaCAIRE INC.CAW2022-05-26
00855573007761VOCSNVentec Life Systems, Inc.CAW2022-04-12
00709078014062InLine Water TrapWESTMED, INC.CAW2022-03-31
00850018761178VOCSN Power SupplyVentec Life Systems, Inc.CAW2022-03-23
00850018761130VOCSNVentec Life Systems, Inc.CAW2021-03-03
00850018761048VOCSN Patient Breathing PackageVentec Life Systems, Inc.CAW2020-10-07