FDA.reportPublic FDA data

Starboard Temperature Probes

Primary DI
10850933007075
Brand
Starboard Temperature Probes
Company
STARBOARD MEDICAL, INC.
Model
40012-ER
Catalog number
40012-ER
Device description
Esophageal/Rectal General Purpose 400 Series Temperature Sensor,12 Fr.
Published
2016-09-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
BZTStethoscope, Esophageal, With Electrical Conductors

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZTStethoscope, Esophageal, With Electrical ConductorsAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111050000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111050000ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, 9FR, 12FR, 18FR, 24FRStarboard Medical, LLC2012-04-12BZT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850933007075PackageGS135In Commercial Distribution
00850933007078PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085093300707510850933007075
00850933007078008509330070788509330070780850933007078

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012983893
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00749756392334DeRoyalDEROYAL INDUSTRIES, INC.BZT2023-07-23
50749756392339DeRoyalDEROYAL INDUSTRIES, INC.BZT2023-07-23
00817499020101LIFESOUNDNOVAMED-USA INC.BZT2023-06-27
00817499020286LIFESOUNDNOVAMED-USA INC.BZT2023-06-27
00817499020293LIFESOUNDNOVAMED-USA INC.BZT2023-06-27
00817499020309LIFESOUNDNOVAMED-USA INC.BZT2023-06-27
00817499020316NOVATEMPNOVAMED-USA INC.BZT2023-06-27
00817499020323NOVATEMPNOVAMED-USA INC.BZT2023-06-27
00817499020330NOVATEMPNOVAMED-USA INC.BZT2023-06-27
00817499020347NOVATEMPNOVAMED-USA INC.BZT2023-06-27
00817499020361NOVATEMPNOVAMED-USA INC.BZT2023-06-27
00817499020378NOVATEMPNOVAMED-USA INC.BZT2023-06-27
00817499020385NOVATEMPNOVAMED-USA INC.BZT2023-06-27
10817499020108LIFESOUNDNOVAMED-USA INC.BZT2023-06-27
10817499020283LIFESOUNDNOVAMED-USA INC.BZT2023-06-27
10817499020290LIFESOUNDNOVAMED-USA INC.BZT2023-06-27
10817499020306LIFESOUNDNOVAMED-USA INC.BZT2023-06-27
10817499020313NOVATEMPNOVAMED-USA INC.BZT2023-06-27
10817499020320NOVATEMPNOVAMED-USA INC.BZT2023-06-27
10817499020337NOVATEMPNOVAMED-USA INC.BZT2023-06-27
10817499020344NOVATEMPNOVAMED-USA INC.BZT2023-06-27
10817499020368NOVATEMPNOVAMED-USA INC.BZT2023-06-27
10817499020375NOVATEMPNOVAMED-USA INC.BZT2023-06-27
10817499020382NOVATEMPNOVAMED-USA INC.BZT2023-06-27
10884521820890Mon-a-ThermCovidien LPBZT2023-05-29
10884521820906Mon-a-ThermCovidien LPBZT2023-05-29
10884521820913Mon-a-ThermCovidien LPBZT2023-05-29
10884521820920Mon-a-ThermCovidien LPBZT2023-05-29
30884521820894Mon-a-ThermCovidien LPBZT2023-05-29
20884521820903Mon-a-ThermCovidien LPBZT2023-05-29