FDA.reportPublic FDA data

Cell Therapy 360 Wearable Tech V1

Primary DI
00851203006104
Brand
Cell Therapy 360 Wearable Tech V1
Company
BLUE SPARK TECHNOLOGIES, INC.
Model
TT-300
Catalog number
622
Published
2020-10-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

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
K201977000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143267000TempTraq TT-100Blue Spark Technologies, Inc.2015-09-02FLL
K201977000TempTraqBlue Spark Technologies, Inc.2020-12-03FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851203006203PrimaryGS10
00851203006227PrimaryGS10
00851203006296PrimaryGS10
00851203006302PrimaryGS10
00851203006319PrimaryGS10
00851203006326PrimaryGS10
00851203006340PrimaryGS10
00851203006357PrimaryGS10
00851203006395PrimaryGS10
00851203006401PrimaryGS10
00851203006418PrimaryGS10
00851203006425PrimaryGS10
00851203006104Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851203006203008512030062038512030062030851203006203
00851203006227008512030062278512030062270851203006227
00851203006296008512030062968512030062960851203006296
00851203006302008512030063028512030063020851203006302
00851203006319008512030063198512030063190851203006319
00851203006326008512030063268512030063260851203006326
00851203006340008512030063408512030063400851203006340
00851203006357008512030063578512030063570851203006357
00851203006395008512030063958512030063950851203006395
00851203006401008512030064018512030064010851203006401
00851203006418008512030064188512030064180851203006418
00851203006425008512030064258512030064250851203006425
00851203006104008512030061048512030061040851203006104

GMDN Terms#

Term, Definition table
TermDefinition
Wireless patient thermometer, single-useA battery-powered electronic device intended to continuously measure body temperature and wirelessly transmit data to a computing device, typically a smartphone or tablet with dedicated software, for data display, recording and analysis. It is in the form of an adhesive patch designed to be placed on the skin (typically in/near the armpit), and is typically used to monitor a fever during daily activities and sleep. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
14402495440info@temptraq.com

Regulatory Flags#

DUNS number
603031365
Device count
10
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09120095900809SteadyTempSteadySense GmbHFLL2026-10-21
06973660370520MinttiSuzhou Melodicare Medical Technology Co., Ltd.FLL2026-10-10
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyFLL2026-10-04
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
00885403523437HemoSphere AltaBecton, Dickinson And CompanyFLL2026-08-06
00885403523451HemoSphere AltaBecton, Dickinson And CompanyFLL2026-08-06
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06970758502641CaremedShenzhen Caremed Medical Technology Co., Ltd.FLL2026-07-09
06970758508865CaremedShenzhen Caremed Medical Technology Co., Ltd.FLL2026-07-09
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00850086928015SENSINEL™ CPM WEARABLEAnalog Devices, Inc.FLL2026-06-03
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00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.FLL2026-06-03
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.FLL2026-06-02
06926347900459joybabeShenzhen Brav Electronic Technologies Co., Ltd.FLL2026-06-01
06942284618073One Step®JOYTECH HEALTHCARE CO.,LTDFLL2026-05-29