Starboard Temperature Probes 40012-ES

GUDID 10850933007037

Esophageal Stethoscope with 400 Series Temperature Sensor, 12 Fr.

STARBOARD MEDICAL, INC.

Electronic oesophageal stethoscope, single-use
Primary Device ID10850933007037
NIH Device Record Key9c812597-ca55-4d66-aa65-315e11a6fefe
Commercial Distribution StatusIn Commercial Distribution
Brand NameStarboard Temperature Probes
Version Model Number40012-ES
Catalog Number40012-ES
Company DUNS012983893
Company NameSTARBOARD MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850933007030 [Primary]
GS110850933007037 [Package]
Contains: 00850933007030
Package: Inner Pack [30 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BZTStethoscope, Esophageal, With Electrical Conductors

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-30

On-Brand Devices [Starboard Temperature Probes]

10850933007105Pediatric Tympanic Temperature Sensor (400 Series Thermistor)
10850933007099Adult Tympanic Temperature Sensor (400 Series Thermistor)
10850933007082Skin Temperature Sensor (400 Series Thermistor)
10850933007075Esophageal/Rectal General Purpose 400 Series Temperature Sensor,12 Fr.
10850933007068Esophageal/Rectal General Purpose 400 Series Temperature Sensor, 9 Fr.
10850933007051Esophageal Stethoscope with 400 Series Temperature Sensor, 24 Fr.
10850933007044Esophageal Stethoscope with 400 Series Temperature Sensor, 18 Fr.
10850933007037Esophageal Stethoscope with 400 Series Temperature Sensor, 12 Fr.
10850933007020Esophageal Stethoscope with 400 Series Temperature Sensor, 9 Fr.

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