FDA.reportPublic FDA data

Homedics

Primary DI
06938395500307
Brand
Homedics
Company
Shenzhen Hexin ZONDAN Medical Equipment Co., Ltd
Model
PX-250HCO
Device description
Homedics pulse oximeter
Published
2026-04-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
PGJOximeter, Wellness

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PGJOximeter, WellnessCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06938395500307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06938395500307069383955003076938395500307

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeterAn electrically-powered photoelectric device designed for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals are produced by light-emitting diodes (LEDs) and received by a photodetector. The device displays the SpO2 values and may also measure/display pulse rate. It is typically applied to the fingertip or around the wrist, may be single-component (with built-in probe) or multi-component (includes external probe), and may in addition wirelessly transmit measurements to a receiving location (e.g., central station, bedside monitor); it is intended to be operated by laypersons and healthcare providers.

Regulatory Flags#

DUNS number
527098717
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06938395500291HomedicsPX-250RCO2026-04-22
06938395500321CONCORD750592026-04-28
06938395500314AccuMedAC-D12026-04-27
06938395500284AccuMedAC-D12026-04-15
06938395500253HomedicsPX-200L2026-03-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850022853067ProSomnus HWO2 DevicePROSOMNUS SLEEP TECHNOLOGIESPGJ2026-04-24
06938395500291HomedicsShenzhen Hexin ZONDAN Medical Equipment Co., LtdPGJ2026-04-22
00786585793505SEJOYJOYTECH HEALTHCARE CO.,LTDPGJ2026-03-28
06942284601921MaynoviaJOYTECH HEALTHCARE CO.,LTDPGJ2026-03-28
06942284601938MaynoviaJOYTECH HEALTHCARE CO.,LTDPGJ2026-03-28
06942284601945MaynoviaJOYTECH HEALTHCARE CO.,LTDPGJ2026-03-28
06942284601952MaynoviaJOYTECH HEALTHCARE CO.,LTDPGJ2026-03-28
06970392211213MaynoviaJOYTECH HEALTHCARE CO.,LTDPGJ2026-03-28
06970392211244SEJOYJOYTECH HEALTHCARE CO.,LTDPGJ2026-03-28
06970392218793MaynoviaJOYTECH HEALTHCARE CO.,LTDPGJ2026-03-28
06970392218724SEJOYJOYTECH HEALTHCARE CO.,LTDPGJ2026-03-27
06938395500253HomedicsShenzhen Hexin ZONDAN Medical Equipment Co., LtdPGJ2026-03-13
00050428168721CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDPGJ2025-09-30
00050428168738CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDPGJ2025-09-30
00846841092695ChoiceMMedBeijing Choice Electronic Technology Co., Ltd.PGJ2025-09-24
B635BIOKIT0100Biokit O2BIOTRICITY INCPGJ2025-09-24
00845717010139Veridian HealthcareVERIDIAN HEALTHCARE LLCPGJ2025-09-09
30845717010130Veridian HealthcareVERIDIAN HEALTHCARE LLCPGJ2025-09-09
00845717011945R.P.M. PROVERIDIAN HEALTHCARE LLCPGJ2025-09-08
00845717012164TrackstarVERIDIAN HEALTHCARE LLCPGJ2025-09-08
00846841092565ChoiceMMedBeijing Choice Electronic Technology Co., Ltd.PGJ2025-07-22
00846841092954ChoiceMMedBeijing Choice Electronic Technology Co., Ltd.PGJ2025-07-22
06942820462498ChoicemmedBeijing Choice Electronic Technology Co., Ltd.PGJ2025-04-27
00850000967014CMI HealthCMI HEALTH INC.PGJ2025-04-23
00850000967038CMI HealthCMI HEALTH INC.PGJ2025-04-23
00850000967052CMI HealthCMI HEALTH INC.PGJ2025-04-23
00850000967311CMI HealthCMI HEALTH INC.PGJ2025-01-17
06941900601406Pulse OximeterShenzhen Creative Industry Co., Ltd.PGJ2024-12-27
06941900603394Pulse OximeterShenzhen Creative Industry Co., Ltd.PGJ2024-12-27
06941900604384Pulse OximeterShenzhen Creative Industry Co., Ltd.PGJ2024-12-27