FDA.reportPublic FDA data

Virtuox

Primary DI
00817698020063
Brand
Virtuox
Company
HEALTHCARE LOGISTICS SYSTEMS LLC
Model
1002
Device description
VPOD Ultra, Pediatric finger clip probe
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
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090671000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090671000PULSE OXIMETER, MODELS CMS50E, CMS50F, CMS60C, CMS60DContec Medical System Co., Ltd.2009-06-11DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817698020063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817698020063008176980200638176980200630817698020063

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeter probe, reusableA photoelectric device applied externally to a body site, e.g., a fingertip, ear lobe, the bridge of nose, a toe, or the bridge of the foot of a paediatric or adult patient for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using light detection. The signals, typically produced by light-emitting diodes (LEDs) and a receiving detector, are received by an oximeter to which this device is connected. The oximeter displays the SpO2 values and may calculate/display other parameters, e.g., electrocardiogram (ECG). This is a reusable device.

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
00817698020032Virtuox13002016-12-07
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
06931973400730CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
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06931973410326CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
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06931973410340CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
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06931973410371CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410388CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
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06931973410432CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
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06931973410692CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410715CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410722CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410739CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09