FDA.reportPublic FDA data

Starboard Temperature Probes

Primary DI
00850933007092
Brand
Starboard Temperature Probes
Company
STARBOARD MEDICAL, INC.
Model
400-TY
Catalog number
400-TY
Device description
Adult Tympanic Temperature Sensor (400 Series Thermistor)
Published
2016-09-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
K111282000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111282000DISPOSABLE TEMPERATURE PROBES / SENSORS AND INTERCONNECT INSTRUMENT CABLESStarboard Medical, LLC2011-08-11FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850933007099PackageGS150In Commercial Distribution
00850933007092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085093300709910850933007099
00850933007092008509330070928509330070920850933007092

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose patient temperature probe, single-useA temperature sensing device intended to be placed into a body orifice or on the body surface, and used in conjunction with a separate parent device with a display (e.g., electronic patient thermometer, infant warmer) to enable measurement/monitoring of a patient’s temperature; its use is not dedicated to a specific type of procedure. It is typically constructed of flexible materials (e.g., plastic or rubber) with a metal conducting core; the distal end of different device types will be designed for a particular application site. This is a single-use device.

Regulatory Flags#

DUNS number
012983893
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850933007009Clik-FIXWCS-1061WCS-10612017-01-30
00850933007016Clik-FIXPCS-1011PCS-10112016-09-30
00850933007139Clik-FIXWCS-1003WCS-10032016-09-30
00850933007146Clik-FIXWCS-1051WCS-10512017-01-30
00850933007184Clik-FIXPCS-1012PCS-10122017-03-16
00850933007191Clik-FIXWCS-1052WCS-10522017-08-07
00850933007221Clik-FIXWCS-1006WCS-10062018-05-30
00866896000018Clik-FIXWCS-1000WCS-10002017-01-24
00850933007269Clik-FIXNPS-1006NPS-10062019-04-18
00850933007153Clik-FIXLLS-1021LLS-10212017-02-27
00850933007160Clik-FIXABS-1022ABS-10222017-03-14
00850933007252Clik-FIXLLS-1024LLS-10242018-10-10
10850933007204Clik-FIXLLSK-1024LLSK-10242019-03-08
20850933007201Clik-FIXLLSK-1024LLSK-10242019-03-08
10850933007242Clik-FIXPCK-1011PCK-10112019-03-08
10850933007006Clik-FIXWCS-1061WCS-10612017-01-30
10850933007013Clik-FIXPCS-1011PCS-10112016-09-30
10850933007136Clik-FIXWCS-1003WCS-10032016-09-30
10850933007143Clik-FIXWCS-1051WCS-10512017-01-30
10850933007181Clik-FIXPCS-1012PCS-10122017-03-16

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