NOVATEMP

GUDID 20817499020044

SKIN TEMPERATURE SENSOR WITH 400 SERIES THERMISTOR

NOVAMED-USA INC.

General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use

• Primary Device ID: 20817499020044
• NIH Device Record Key: 9c528d6e-09a3-4f03-8840-e2fe44ed8dc4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NOVATEMP
• Version Model Number: 10-1600-001
• Company DUNS: 831531426
• Company Name: NOVAMED-USA INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817499020040 [Primary]
GS1	10817499020047 [Package]; Contains: 00817499020040; Package: BOX [30 Units]; In Commercial Distribution
GS1	20817499020044 [Package]; Contains: 10817499020047; Package: CASE [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062020

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-03

On-Brand Devices [NOVATEMP]

• 20817499020204: SKIN TEMPERATURE SENSOR WITH 700 SERIES THERMISTOR
• 20817499020198: 30mm MYOCARDIAL TEMPERATURE PROBE WITH 400 SERIES THERMISTOR
• 20817499020181: 15mm MYOCARDIAL TEMPERATURE PROBE WITH 400 SERIES THERMISTOR
• 20817499020075: 12FR ESOPHAGEAL/RECTAL TEMPERATURE PROBE WITH 400 SERIES THERMISTOR
• 20817499020068: 10FR ESOPHAGEAL/RECTAL TEMPERATURE PROBE WITH 400 SERIES THERMISTOR
• 20817499020051: 9FR ESOPHAGEAL/RECTAL TEMPERATURE PROBE WITH 400 SERIES THERMISTOR
• 20817499020044: SKIN TEMPERATURE SENSOR WITH 400 SERIES THERMISTOR
• 10817499020443: ADULT TYMPANIC PROBE WITH 400 SERIES THERMISTOR STERILE - 1 EACH
• 10817499020436: SKIN TEMPERATURE SENSOR WITH 400 SERIES THERMISTOR STERILE - 1 EACH
• 10817499020429: 44MM Myocardial temperature probe/400 series sterile - each
• 10817499020412: 30MM Myocardial temperature probe/400 series sterile - each
• 10817499020405: 15MM Myocardial temperature probe/400 series sterile- each
• 10817499020399: Adult tympanic probe with 400 series thermistor - 1 each
• 10817499020382: 12FR esophageal/rectal temperature probe/400 series sterile - each
• 10817499020375: 10FR esophageal/rectal temperature probe/400 series sterile - each
• 10817499020368: 9FR esophageal/rectal temperature probe/400 series sterile - each
• 00817499020354: Skin Temperature Sensor/400 series sterile - each
• 10817499020344: 10FR GENERAL PURPOSE PROBE WITH 400 SERIES THERMISTOR STERILE - 1 EACH
• 10817499020337: 24FR ESOPHAGEAL STETHOSCOPE WITH 400 SERIES THERMISTOR STERILE - 1 EACH
• 10817499020320: 18FR ESOPHAGEAL STETHOSCOPE WITH 400 SERIES THERMISTOR STERILE - 1 EACH
• 10817499020313: 12FR ESOPHAGEAL STETHOSCOPE WITH 400 SERIES THERMISTOR STERILE - 1 EACH
• 00817499020576: 12' (3.6M) REUSABLE TEMP ADAPTER CABLE WITH 7 PIN DIN CONNECTOR FOR DRAEGER INFINITY/ SIEMENS S
• 00817499020569: 4' (1.2M) REUSABLE TEMPERATURE ADAPTER CABLE WITH 7 PIN DIN CONNECTOR FOR DRAEGER INFINITY/ SIEM
• 00817499020552: 12' (3.6M) REUSABLE TEMPERATURE ADAPTER CABLE WITH STRAIGHT 1/4" PHONO PLUG AND 1/8" PHONO JACK,
• 00817499020545: 20' (6.0M) REUSABLE PHILIPS TEMPERATURE ADAPTER CABLE WITH 2 PIN DIN CONNECTOR AND 1/8" PHONO JA
• 00817499020538: 12' (3.6M) REUSABLE PHILIPS TEMPERATURE ADAPTER CABLE WITH 2 PIN DIN CONNECTOR AND 1/8" PHONO JA
• 00817499020521: 12' (3.6M) REUSABLE TEMPERATURE ADAPTER CABLE WITH 1/4" RIGHT ANGLE PHONO PLUG AND 1/8" PHONO JA
• 00817499020514: 20' (6.0M) REUSABLE TEMPERATURE ADAPTER CABLE WITH STRAIGHT 1/4" PHONO PLUG, 400 SERIES
• 00817499020507: 12' (3.6M) REUSABLE TEMPERATURE ADAPTER CABLE WITH STRAIGHT 1/4" PHONO PLUG, 400 SERIES
• 00817499020491: 10' (3.0M) REUSABLE TEMPERATURE ADAPTER CABLE WITH STRAIGHT 1/4" PHONO PLUG, 400 SERIES
• 00817499020484: 20' (6.0M) REUSABLE PHILIPS (HP) TEMPERATURE ADAPTER CABLE WITH 2 PIN DIN CONNECTOR, 400 SERIES
• 00817499020477: 12' (3.6M) REUSABLE PHILIPS (HP) TEMPERATURE ADAPTER CABLE WITH 2 PIN DIN CONNECTOR, 400 SERIES
• 00817499020460: 20' (6.0M) REUSABLE TEMPERATURE ADAPTER CABLE WITH 1/4" RIGHT ANGLE PHONO PLUG, 400 SERIES
• 00817499020453: 12' (3.6M) REUSABLE TEMPERATURE ADAPTER CABLE WITH 1/4" RIGHT ANGLE PHONO PLUG, 400 SERIES