Starboard Temperature Probes 4009-ER

GUDID 10850933007068

Esophageal/Rectal General Purpose 400 Series Temperature Sensor, 9 Fr.

STARBOARD MEDICAL, INC.

General-purpose patient temperature probe, single-use

• Primary Device ID: 10850933007068
• NIH Device Record Key: d3a04ea6-508b-49e7-8e4b-490a764d7317
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Starboard Temperature Probes
• Version Model Number: 4009-ER
• Catalog Number: 4009-ER
• Company DUNS: 012983893
• Company Name: STARBOARD MEDICAL, 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: true
• Expiration Date: true
• 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	00850933007061 [Primary]
GS1	10850933007068 [Package]; Contains: 00850933007061; Package: Inner Pack [35 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111050

FDA Product Code

• BZT: Stethoscope, Esophageal, With Electrical Conductors

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-30

On-Brand Devices [Starboard Temperature Probes]

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