FDA.reportPublic FDA data

Smarttemp Infant Bluetooth Thermometer

Primary DI
00050428557969
Brand
Smarttemp Infant Bluetooth Thermometer
Company
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Model
WT-1
Device description
The smarttemp’s continuous monitoring is the easiest way to track baby’s temperature all day/night long! It sends an alert to a smart phone when fever
Published
2016-09-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
true
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FLLThermometer, Electronic, Clinical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00050428557969PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00050428557969000504285579690504285579690050428557969

GMDN Terms#

Term, Definition table
TermDefinition
Continuous electronic patient thermometer, battery-poweredA battery-powered, electronic instrument designed to continuously measure (monitor) a patient's body temperature (e.g., during the administration of general anaesthesia, treatment of hypothermia and hyperthermia). It comprises an electronic unit and an attached probe that detects and converts the changes in temperature into variations of an electric characteristic, e.g., resistance or voltage. These variations of the electric characteristic are processed in the electronic circuits and continuously displayed as temperature readings. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature70 Degrees Fahrenheit110 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8554222983giuseppe@infanttech.com

Regulatory Flags#

DUNS number
062312574
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00050428005583CVS 689466LB152026-01-28
10050428005603CVS 689509LB262026-01-26
10050428005610CVS 689573LB462026-01-23
10050428273484CVS Health TamponsBCVGC32(L/R)2025-12-31
00050428005842CVS 695535BM332025-12-11
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Primary DI, Brand, Company table
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06970289035144hetaidaHetaida Technology Co., LtdFLL2026-05-23
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40328785013984BRAUNKAZ USA, INC.FLL2026-02-04
10328785007975BraunKAZ USA, INC.FLL2026-02-03
00328785008272BraunKAZ USA, INC.FLL2026-02-03
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00328785014655BRAUNKAZ USA, INC.FLL2026-01-28
00328785014662BRAUNKAZ USA, INC.FLL2026-01-27
00328785014716BRAUNKAZ USA, INC.FLL2026-01-27
10311917052264WalgreensWALGREEN CO.FLL2025-12-31
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10850044118707iHealthIHEALTH LAB INC.FLL2025-12-19