FDA.report

Cell Therapy 360 Wearable Tech V1

Primary DI
00851203006241
Brand
Cell Therapy 360 Wearable Tech V1
Company
BLUE SPARK TECHNOLOGIES, INC.
Model
2.6.1 (1106) CV
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
false

Related Records

Product Codes

CodeName
FLLThermometer, Electronic, Clinical

Product Code Classifications

CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Premarket Submissions

SubmissionSupplement
K143267000

Premarket Details

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00851203006241PrimaryGS10

GMDN Terms

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

Contacts

PhoneEmail
14402495440info@temptraq.com

Regulatory Flags

DUNS number
603031365
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 DIBrandModelCatalogPublished
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
00851203006050TempTraq®TT-1006212020-10-21
00851203006104Cell Therapy 360 Wearable Tech V1TT-3006222020-10-21
00851203006234Cell Therapy 360 Wearable Tech V12.6.0.10813 CV2020-10-21
00851203006258Cell Therapy 360 Wearable Tech V12.6.0 (1099) R2020-10-21
00851203006265Cell Therapy 360 Wearable Tech V12.6.0.10768 PC2020-10-21
00851203006272Cell Therapy 360 Wearable Tech V12.3.0.10160 CV2020-10-21
00851203006197TempTraq®TT-3006192020-01-22
00851203006173TempTraq®TempTraq Clinician Web App2019-04-29
00851203006036TempTraqTempTraq Consumer Android App2016-08-26
00851203006043TempTraqTempTraq Consumer iOS App2016-08-26
00851203006111TempTraq®TempTraq Patient Android App2018-02-15
00851203006128TempTraq®TempTraq Clinician Android App2018-02-15
00851203006135TempTraq®TempTraq Patient iOS App2018-03-22

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