FDA.reportPublic FDA data

Patient Monitor

Primary DI
06941900604285
Brand
Patient Monitor
Company
Shenzhen Creative Industry Co., Ltd.
Model
PC-3000
Published
2021-02-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
DQAOximeter
DXNSystem, Measurement, Blood-Pressure, Non-Invasive
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAnesthesiology2
DQAOximeterCardiovascular2
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123711000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123711000PATIENT MONITORShenzhen Creative Industry Co., Ltd.2013-10-01MWI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06941900604285PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06941900604285069419006042856941900604285

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose multi-parameter bedside monitorAn electrically-powered device/device assembly designed for the continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one patient in intensive or general healthcare settings. It typically set-up by the patient bedside and often includes programmable alarms, portable radio transmitters, receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation; it is not dedicated to neonatal use.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
547908801
Device count
1
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
06941900601406Pulse OximeterKW-68B2024-12-27
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06946725572900APKAPK Technology Co.,Ltd.DQA2026-10-26
06946725572948APKAPK Technology Co.,Ltd.DQA2026-10-26
10860015046007XChangePneuma Therapeutics, Inc.CCK2026-10-16
06946725516188APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516195APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516201APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516218APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516225APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516232APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516249APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516256APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516263APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516270APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516287APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516300APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516317APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516324APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516331APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516348APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516355APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516362APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516379APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516386APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516393APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516409APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516416APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516423APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516430APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516447APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516454APKAPK Technology Co.,Ltd.DQA2026-03-11