FDA.reportPublic FDA data

TigerConnect Alarm Management

Primary DI
00860006582012
Brand
TigerConnect Alarm Management
Company
Critical Alert
Device description
TigerConnect (TC) Alarm Management is a software as a medical device (SaMD) capable of acquiring alarms, events, and parameters from healthcare systems, and intelligently forwarding this information as secondary notifications to designated commercial endpoint devices. The endpoint devices act as non-regulated medical device data system (MDDS) devices that display the information from TC Alarm Management. TC Alarm Management is intended for use as a secondary alarm; it does not replace the alarm function on the primary device.
Published
2026-05-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
MSXSystem, Network And Communication, Physiological Monitors
PHCInfusion Safety Management Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MSXSystem, Network And Communication, Physiological MonitorsCardiovascular2
PHCInfusion Safety Management SoftwareGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243270000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243270000TigerConnect Alarm ManagementTigerconnect2025-09-30MSX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860006582012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860006582012008600065820128600065820120860006582012

GMDN Terms#

Term, Definition table
TermDefinition
Alarm application softwareAn individual software application program or group of programs, routines or algorithms designed for use in, or together with, an alarm device to enable it to function according to its intended purpose. The basic set of applications programs and routines can be upgraded to correct programming errors or to add new system capabilities. Application program packages are typically identified by a proprietary name and "version" or "upgrade" number. This software may also be produced for installation in an off-the-shelf desktop or laptop computer.

Regulatory Flags#

DUNS number
112008769
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
false
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
00860006582005CommonPath Enterprise2021-04-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.MSX2026-06-02
08720256776659Strap Silicon BlueCorsano Health B.V.MSX2026-06-02
08720256776987Charge Station 10 Sensors ACorsano Health B.V.MSX2026-06-02
00884838107816Measurement Rack 6000Philips Medizin Systeme Böblingen GmbHMSX2026-05-19
00884838129238Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2026-04-17
00884838129245Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2026-04-17
B153300010AirStrip ONE PlatformAirstrip Technologies, Inc.MSX2026-03-18
B153301030AirStrip ONE Client WebAirstrip Technologies, Inc.MSX2026-03-18
B153500010AirStrip Alarm ManagementAirstrip Technologies, Inc.MSX2026-03-18
00884838129214Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2026-03-09
00884838129221Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2026-03-09
00843997019019Patient SafetyNet LiteMASIMO CORPORATIONMSX2026-02-23
10885403519475BD AlarisCAREFUSION 303, INC.PHC2025-12-23
00195278990914Portrait CSSXBGe Medical Systems Information Technologies, Inc.MSX2025-12-10
00198953024096Portrait CVAXBGe Medical Systems Information Technologies, Inc.MSX2025-12-10
00198953030981PORTRAIT HSWXBGE Healthcare Finland OyMSX2025-12-10
00884838127456Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2025-11-17
00884838127463Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2025-11-17
00851725007399Central StationNihon Kohden Digital Health Solutions, LLCMSX2025-06-30
00853858006584EmpaticaEMPATICA SRLMSX2025-06-26
00887709127227LifeShield Infusion Safety Software SuiteICU Medical, Inc.PHC2025-05-23
00887709127234LifeShield Infusion Safety Software SuiteICU Medical, Inc.PHC2025-05-23
00887709127241LifeShield Infusion Safety Software SuiteICU Medical, Inc.PHC2025-05-23
00884838127432Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2025-05-06
00884838127449Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2025-05-06
G2871002HUMAMedoPad Inc.MSX2025-04-28
00850064210262Sibel Spacelabs Trek TabletSibel Health Inc.MSX2025-04-02
00850064210163Central Hub CMSSibel Health Inc.MSX2025-03-27
00850064210194Central Hub SpeakerSibel Health Inc.MSX2025-03-27
00850064210132ANNE View Patient MonitorSibel Health Inc.MSX2025-03-26