FDA.reportPublic FDA data

OXTM

Primary DI
06973632410155
Brand
OXTM
Company
Oxytek Medical Technology Co., Ltd.
Model
OX-1B
Published
2026-10-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K254289000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K254289000Portable Oxygen Concentrator (OX-1A-E, OX-1B)Oxytek Medical Technology Co., Ltd.2026-09-23CAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973632410155PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973632410155069736324101556973632410155

Regulatory Flags#

DUNS number
560426796
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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
06973632410070OXTMOX-5A2026-10-15
06973632410100OXTMOX-1A-E2026-10-15
06973632410124OXTMOX-5C2026-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00822383027180DECO, 5L Oxygen ConcentratorDrive Devilbiss HealthcareCAW2026-10-29
00822383035482SIMO2, Portable Oxygen ConcentratorDrive Devilbiss HealthcareCAW2026-10-29
00822383036885SIMO2, Portable Oxygen Concentrator, Extended BatteryDrive Devilbiss HealthcareCAW2026-10-29
06973632410070OXTMOxytek Medical Technology Co., Ltd.CAW2026-10-15
06973632410100OXTMOxytek Medical Technology Co., Ltd.CAW2026-10-15
06973632410124OXTMOxytek Medical Technology Co., Ltd.CAW2026-10-15
06970384252163SCIANHONSUN (NANTONG) CO.,LTDCAW2026-07-30
06975247360078HarveyMedShenzhen HarveyMed Technology Co., Ltd.CAW2026-07-30
06975247360085HarveyMedShenzhen HarveyMed Technology Co., Ltd.CAW2026-07-30
06975247360092HarveyMedShenzhen HarveyMed Technology Co., Ltd.CAW2026-07-30
16970384252160SCIANHONSUN (NANTONG) CO.,LTDCAW2026-07-30
26970384252167SCIANHONSUN (NANTONG) CO.,LTDCAW2026-07-30
06975247360061HarveyMedShenzhen HarveyMed Technology Co., Ltd.CAW2026-07-27
00841447114635Invacare® Platinum Oxygen ConcentratorINVACARE CORPORATIONCAW2026-07-21
00841447114642Invacare® Perfecto2V Oxygen ConcentratorINVACARE CORPORATIONCAW2026-07-21
00810178889624Vive BreatheVIVE HEALTH LLCCAW2026-06-01
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
15060031380191RUGGED OXYGEN GENERATOR (ROG)MOLECULAR PRODUCTS LIMITEDCAW2026-04-21
00810178884452ViveBreatheVIVE HEALTH LLCCAW2026-01-30
06977388230012WeOxyWeoxy Co., LTD.CAW2025-09-25
06977388230029WeOxyWeoxy Co., LTD.CAW2025-09-25
06977388230036WeOxyWeoxy Co., LTD.CAW2025-09-25
M766AS200SW460AryaCAIRE INC.CAW2025-08-13
00860012953301MICITECHFoshan MIC Medical Technology Co.,Ltd.CAW2024-11-28