FDA.reportPublic FDA data

VitalPatch® Active Biosensor

Primary DI
00850490007153
Brand
VitalPatch® Active Biosensor
Company
Vital Connect, Inc.
Model
3012-01
Published
2017-05-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152139000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152139000Vital Connect Platform, HealthPatch MD, VitalPatchVitalconnect, Inc.2015-12-06DRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850490007122PackageGS120In Commercial Distribution
00850490007153PackageGS15In Commercial Distribution
00850490007146PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850490007122008504900071228504900071220850490007122
00850490007153008504900071538504900071530850490007153
00850490007146008504900071468504900071460850490007146

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiography telemetric monitoring systemAn assembly of devices designed to continuously measure and wirelessly transmit electrocardiographic (ECG) signals from a patient to a receiving location (e.g., central station, bedside monitor) for viewing. It typically consists of a portable transmitter with antenna and attached sensors (e.g., leads and electrodes) that are connected to the patient, as well as a receiver typically incorporated into a central station or bedside monitor that receives, consolidates, and displays the information. The system is typically used for ambulatory patients who require continuous monitoring (e.g., patients in step-down care areas).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
944642730
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850490007344VitalPatch 2.03037-013047-012019-07-25
00850490007511Holter Kit (Wi-Fi Only)2400-012400-012023-08-31
00850490007481VistaPhone8303-038303-032023-03-31
00850490007504VistaPhone Compact Cardiac Monitoring Kit1500-011400-022023-03-31
00850490007283VitalPatch Adhesive Overlay3801-013801-012019-03-26
00850490007467VistaPhone8303-028303-022021-01-15
00850490007252Vista Solution® 30-day Monitoring Kit9430-019430-012020-11-04
00850490007269Vista Solution® 10-day Evaluation Kit9410-019410-012020-11-04
00850490007313Vista Solution® 2.0 10-day Evaluation Kit9510-019510-012020-11-04
00850490007368VistaTablet™ 2.0 RELAY (W/O VCI Box)8102-018102-012020-11-04
00850490007238VitalPatch 2.03037-013037-012020-11-03
00850490007375VistaCenter6200-036200-032020-11-02
00850490007382VistaPoint Software User Interface6100-036100-032020-11-02
00850490007399VistaTablet8103-018103-012020-11-02
00850490007412Vista Solution 3 10-day Evaluation Kit961096102020-11-02
00850490007429VistaTablet8203-018203-012020-11-02
00850490007436VistaPhone8303-018303-012020-11-02
00850490007443VitalConnect 14-day Cardiac Monitoring Kit1400-021400-022020-11-02
00850490007450VitalPatch® RTM 4007-014007-012020-11-02
00850490007207VistaTablet8101-018101-012018-08-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884838132320Patient Information Center iXPhilips Medizin Systeme Böblingen GmbHMHX2026-07-13
00884838132337Care AssistPhilips Medizin Systeme Böblingen GmbHMHX2026-07-13
00884838132344Care AssistPhilips Medizin Systeme Böblingen GmbHMHX2026-07-13
04048675723639Vista 300Shanghai Draeger Medical Instrument Co.,Ltd.MHX2026-07-13
04048675723646Vista 300Shanghai Draeger Medical Instrument Co.,Ltd.MHX2026-07-13
04048675785477Vista CMSShanghai Draeger Medical Instrument Co.,Ltd.MHX2026-07-13
04048675785484Vista CMSShanghai Draeger Medical Instrument Co.,Ltd.MHX2026-07-13
04048675785491Vista CMSShanghai Draeger Medical Instrument Co.,Ltd.MHX2026-07-13
04048675786108Vista CMSShanghai Draeger Medical Instrument Co.,Ltd.MHX2026-07-13
04048675797173Vista 300 SShanghai Draeger Medical Instrument Co.,Ltd.MHX2026-07-13
04048675797180Vista 300 SShanghai Draeger Medical Instrument Co.,Ltd.MHX2026-07-13
04048675797197Vista 300 SShanghai Draeger Medical Instrument Co.,Ltd.MHX2026-07-13
00198953205716CARESCAPE Telemetry ServerGe Medical Systems Information Technologies, Inc.MHX2026-06-05
00884838119017Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119024Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119031Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119048Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119055Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119062Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119185Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119192Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119208Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119215Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119222Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119079Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-26
00884838119086Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-26
00884838119093Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-26
00884838119109Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-26
00884838119116Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-26
00884838119123Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-26