FDA.reportPublic FDA data

WVSM Wireless Vital Signs Monitor

Primary DI
B3945700047020
Brand
WVSM Wireless Vital Signs Monitor
Company
ATHENA GTX, INC.
Model
miniCap Sidestream
Catalog number
570-0047-02
Device description
miniCap Sidestream
Published
2021-10-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
DQAOximeter
DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
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
DRGTransmitters And Receivers, Physiological Signal, RadiofrequencyCardiovascular2
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191989000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191989000WVSM (Wireless Vital Signs Monitor) RWC + miniCapAthena Gtx2020-01-29MWI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B3945700047020PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system module, multiple-gasA small unit dedicated to the measurement of various gas concentrations, e.g., anaesthetic agents, oxygen (O2), carbon dioxide (CO2), in inspired and expired air obtained through a sampling tube connected to a main respiratory channel (mainstream) or a side-channel (sidestream) of a breathing circuit. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot and the parent device then operates as a mainframe computer displaying the parameters measured and provided by this module.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5152883360info@athenagtx.com

Regulatory Flags#

DUNS number
048031913
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalWVSM Pro Charger406-0056-012026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalWVSM Pro Power Cord467-0047-012026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalWVSM Pro500-0030-012026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalWVSM Pro Temperature Probe Adapter Cable530-0046-012026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalWVSM Pro 12-Lead530-0054-012026-05-27
B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalWVSM Pro 5-Lead530-0054-022026-05-27
B3945600013020WVSM Pro, Wireless Vital Signs Monitor ProfessionalMasimo Mainstream (with Ferrite)560-0013-022026-05-27
B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalNIBP Extension 1' (Dual male connectors)570-0048-012026-05-27
B3945700048020WVSM Pro, Wireless Vital Signs Monitor ProfessionalNIBP Extension 2' (Dual male connectors)570-0048-022026-05-27
B3945700048030WVSM Pro, Wireless Vital Signs Monitor ProfessionalNIBP Extension 3' (Dual male connectors)570-0048-032026-05-27
B3945700048040WVSM Pro, Wireless Vital Signs Monitor ProfessionalNIBP Extension 4' (Dual male connectors)570-0048-042026-05-27
B3945700048050WVSM Pro, Wireless Vital Signs Monitor ProfessionalNIBP Extension 5' (Dual male connectors)570-0048-052026-05-27
B3945700048060WVSM Pro, Wireless Vital Signs Monitor ProfessionalNIBP Extension 6' (Dual male connectors)570-0048-062026-05-27
B3945700048070WVSM Pro, Wireless Vital Signs Monitor ProfessionalNIBP Extension 7' (Dual male connectors)570-0048-072026-05-27
B3945700048080WVSM Pro, Wireless Vital Signs Monitor ProfessionalNIBP Extension 8' (Dual male connectors)570-0048-082026-05-27
B3945700048090WVSM Pro, Wireless Vital Signs Monitor ProfessionalNIBP Extension 9' (Dual male connectors)570-0048-092026-05-27
B3945700048100WVSM Pro, Wireless Vital Signs Monitor ProfessionalNIBP Extension 10' (Dual male connectors)570-0048-102026-05-27
B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalNonin Fingerclip extension (with Ferrite)570-0051-022026-05-27
B3945700063010WVSM Pro, Wireless Vital Signs Monitor ProfessionalNonin Xpod570-0063-012026-05-27
B3945700064010WVSM Pro, Wireless Vital Signs Monitor ProfessionalMasimo uSpO2570-0064-012026-05-27

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