FDA.reportPublic FDA data

McKesson

Primary DI
10612479248158
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
146-525DS
Device description
CONCENTRATOR, OXYGEN 5LTR W/OXY SENSOR
Published
2019-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
K071397000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071397000DEVILBISS 5 LITER COMPACT OXYGEN CONCENTRATOR, MODEL 525 SERIESSunrise Medical2007-10-01CAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10612479248158PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1061247924815810612479248158

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
023904428
Device count
1
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20612479282852McKessonM-1669H2026-05-26
20612479282883McKessonM-662G2026-05-26
20612479282890McKessonM-1667G2026-05-26
20612479282906McKessonM-1667H2026-05-26
20612479282913McKessonM-698G2026-05-26
20612479282920McKessonM-1666G2026-05-26
20612479282937McKessonM-1698G2026-05-26
20612479282944McKessonM-663G2026-05-26
20612479283019McKessonM-699G2026-05-26
20612479283194McKessonM-8699G2026-05-26
20612479283200McKessonM-8682G2026-05-26
20612479283217McKessonM-8698G2026-05-26
20612479283224McKessonM-8686G2026-05-26
20612479283231McKessonM-8697G2026-05-26
20612479283248McKessonM-8695G2026-05-26
20612479283255McKessonM-685G2026-05-26
20612479283385McKessonM-J494G2026-05-26
20612479283392McKessonM-J496G2026-05-26
20612479283408McKessonM-J493G2026-05-26
20612479283415McKessonM-J546G2026-05-26

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