FDA.reportPublic FDA data

Virtuox

Primary DI
00817698020032
Brand
Virtuox
Company
HEALTHCARE LOGISTICS SYSTEMS LLC
Model
1300
Device description
VPOD Capox, Handheld Capnography and Pulse Oximetry Device
Published
2016-12-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAnesthesiology2
DQAOximeterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093016000
K170820000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093016000VITAL SIGNS MONITORShenzhen Creative Industry Co., Ltd.2010-03-30DQA
K170820000Capnograph and OximeterCmi Health, Inc.2018-07-18CCK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817698020032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817698020032008176980200328176980200320817698020032

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeter, battery-poweredA portable, battery-powered, photoelectric device intended for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals, typically produced by light-emitting diodes (LEDs) and a receiving detector in a probe, or directly built-in, are used to make the measurements using the principle of spectrophotometry. The oximeter displays the SpO2 values and may calculate/display other parameters, e.g., pulse rate, electrocardiogram (ECG). The device is typically applied to the fingertip or around the wrist; it may be used by healthcare facilities, emergency services, or in the home.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-337-7111sales@virtuox.net

Regulatory Flags#

DUNS number
079452927
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817698020728HLS13002026-01-06
00817698020698Healthcare Logistics Systems80502025-05-01
00817698020704Healthcare Logistics Systems15502025-05-01
00817698020711Healthcare Logistics Systems12502025-05-01
10817698020275Virtuox18502016-12-07
10817698020282Virtuox18512016-12-07
10817698020299Virtuox18532016-12-07
10817698020305Virtuox18522016-12-07
00817698020681Healthcare Logiix SystemsDream2024-05-01
10817698020190Virtuox18002016-12-07
10817698020206Virtuox18012016-12-07
10817698020213Virtuox18022016-12-07
10817698020220Virtuox18032016-12-07
10817698020237Virtuox12042016-12-07
10817698020244Virtuox12052016-12-07
10817698020251Virtuox12062016-12-07
10817698020268Virtuox12072016-12-07
10817698020312Virtuox19002016-12-07
10817698020329Virtuox19502016-12-07
90817698020592VirtuoxSPo2T2021-01-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048675723677Vista 300 Sidestream CO2 ModuleShanghai Draeger Medical Instrument Co.,Ltd.CCK2026-07-13
04048675785910Masimo SpO2 Module for Vista 300/SShanghai Draeger Medical Instrument Co.,Ltd.DQA2026-07-13
00010939962218N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00093351041099N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00845717013550N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00845717013567N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06972040113849N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06972040113856N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06931973400563CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
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06931973410715CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410722CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09