FDA.reportPublic FDA data

Cell Therapy 360 Wearable Tech V1

Primary DI
00851203006265
Brand
Cell Therapy 360 Wearable Tech V1
Company
BLUE SPARK TECHNOLOGIES, INC.
Model
BMS CT360 Andriod Clinician App
Device description
BMS CT360 Andriod Clinician App
Published
2020-10-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FLLThermometer, Electronic, Clinical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143267000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143267000TempTraq TT-100Blue Spark Technologies, Inc.2015-09-02FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851203006265PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851203006265008512030062658512030062650851203006265

GMDN Terms#

Term, Definition table
TermDefinition
Wireless patient monitor/sensor reporting softwareA software program intended to wirelessly receive data from a noninvasive, patient-worn, wireless monitor/sensor to display, record, and assist in analysis and healthcare provider reporting reporting of the collected clinical data, typically for continuous monitoring, and optional communication with a clinician. It may enable configuration of alert notifications and is typically installed in an off-the-shelf, portable, computerized device (e.g., smartphone, tablet) for use in the home or healthcare facility; it is not dedicated to bedside monitoring.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
603031365
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851203006296TempTraq®TT-3002021-02-10
00851203006302TempTraq®TT-3006302021-02-10
00851203006319TempTraq®TT-3006312023-06-30
00851203006326TempTraq®TT-3006322023-06-30
00851203006340TempTraq®TT-3006342024-03-06
00851203006357TempTraq®TT-3006352026-02-26
00851203006395TempTraq®TT-3006392026-02-26
00851203006401TempTraq®TT-3006402026-02-26
00851203006418TempTraq®TT-3006412026-02-26
00851203006425TempTraq®TT-3006422026-02-26
00851203006456TempTraq®TT-1006452025-11-14
00851203006463TempTraq®TT-1006462025-11-14
00851203006449TempTraq®4.x.x2026-02-26
00851203006470TempTraq®TT-1006472026-02-26
00851203006487TempTraq®TT-3006482026-02-26
00851203006432TempTraq®4.x.x2025-03-05
00851203006364TempTraq®4.x.x2025-02-25
00851203006371TempTraq®4.x.x2025-02-25
00851203006388TempTraq®4.x.x2025-02-25
00851203006227Cell Therapy 360 Wearable Tech V1TT-3006222020-10-21

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Primary DI, Brand, Company table
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00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyFLL2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyFLL2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyFLL2026-10-04
00749756389181DeRoyalDEROYAL INDUSTRIES, INC.FLL2026-09-21
00749756389204DeRoyalDEROYAL INDUSTRIES, INC.FLL2026-09-21
06944413835153Telemetry MonitorEdan Instruments, Inc.FLL2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.FLL2026-08-26
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06972040114334N/AShenzhen AOJ Medical Technology Co., LtdFLL2026-07-11
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