FDA.reportPublic FDA data

Pulse Oximeter

Primary DI
06934440102922
Brand
Pulse Oximeter
Company
Shenzhen Viatom Technology Co.,Ltd.
Model
S1
Published
2024-12-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
06934440102922PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06934440102922069344401029226934440102922

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
421357243
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06934440102021VIATOM Pulse OximeterPO22025-11-12
06934440102977LEPU MEDICALPO22025-03-17
06934440103066Pulse OximeterPO22025-03-17
06934440103073Pulse OximeterPO2A2025-03-17
06934440103080Pulse OximeterPO2B2025-03-17
06934440102311ViatomPO6 Oxyfit Pulse Oximeter2023-12-12
06934440102069CheckmeBP2 Blood Pressure Monitor2024-12-24
06934440102212Wellue/ViatomBP2 Blood Pressure Monitor2024-12-24
06934440102588LEPU MEDICALBP2 Blood Pressure Monitor2024-12-24
06934440102618BP2 Blood Pressure MonitorBP2 Blood Pressure Monitor2024-12-24
06934440102748CheckmeBP2A Blood Pressure Monitor2024-12-24
06934440102755BP2A Blood Pressure MonitorBP2A Blood Pressure Monitor2024-12-24
06934440102762LEPU MEDICALBP2A Blood Pressure Monitor2024-12-24
06934440102809Pulse OximeterS92024-12-23
06934440102816Pulse OximeterS102024-12-23
06934440102823Pulse OximeterS112024-12-23
06934440102830Pulse OximeterS122024-12-23
06934440102847Pulse OximeterS132024-12-23
06934440102854Pulse OximeterS13B2024-12-23
06934440102861Pulse OximeterS142024-12-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00845717013574SMARTHEARTVERIDIAN HEALTHCARE LLCPGJ2026-09-29
00845717013765SMARTHEARTVERIDIAN HEALTHCARE LLCPGJ2026-09-29
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00050428167342CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDPGJ2026-07-10
00850022853067ProSomnus HWO2 DevicePROSOMNUS SLEEP TECHNOLOGIESPGJ2026-04-24
06938395500291HomedicsShenzhen Hexin ZONDAN Medical Equipment Co., LtdPGJ2026-04-22
06938395500307HomedicsShenzhen 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