FDA.reportPublic FDA data

Pulse Oximeter

Primary DI
06941900601406
Brand
Pulse Oximeter
Company
Shenzhen Creative Industry Co., Ltd.
Model
KW-68B
Published
2024-12-27
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
06941900601406PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06941900601406069419006014066941900601406

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
547908801
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
06941900601314Pulse OximeterKS-22024-12-27
06941900601321Pulse OximeterKS-60NW2024-12-27
06941900601338Pulse OximeterKS-60NWB2024-12-27
06941900601345Pulse OximeterS52024-12-27
06941900601352Pulse OximeterS5W2024-12-27
06941900601369Pulse OximeterS5B2024-12-27
06941900601376Pulse OximeterS5WB2024-12-27
06941900601383Pulse OximeterS5G2024-12-27
06941900601390Pulse OximeterS5WG2024-12-27
06941900603394Pulse OximeterPC-66H2024-12-27
06941900604384Pulse OximeterPC-66L2024-12-27
06941900600492Pulse OximeterKS-60F2024-12-26
06941900600508Pulse OximeterKS-60FB2024-12-26
06941900600607Pulse OximeterKS-60FW2024-12-26
06941900600614Pulse OximeterKS-60FWB2024-12-26
06941900604407Pulse OximeterPC-60F2023-08-08
06941900604414Pulse OximeterPC-60FW2023-08-03
06941900603011Pulse OximeterPC-60A2020-05-28
06941900603240Pulse OximeterPC-60NW2020-05-28
06941900604001Handheld Pulse OximeterSP-202019-08-27

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
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
00850000967052CMI HealthCMI HEALTH INC.PGJ2025-04-23
00850000967311CMI HealthCMI HEALTH INC.PGJ2025-01-17
06941900603394Pulse OximeterShenzhen Creative Industry Co., Ltd.PGJ2024-12-27
06941900604384Pulse OximeterShenzhen Creative Industry Co., Ltd.PGJ2024-12-27