STARBOARD MEDICAL, INC.

Address:18001 Sky Park Circle,Irvine,CA,92614,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Stethoscope, Esophageal, With Electrical Conductors (BZT) (6) Device, Intravascular Catheter Securement (KMK) (2) Thermometer, Electronic, Clinical (FLL) (2)

Premarket Exempt

No Yes

Clear

Clik-FIX - 00850933007009 Catalog Number : WCS-1061

Device Description : Clik-FIX Securement System for non-cut to length catheters secured with block.

Device Class : 1

Duns Number: 012983893

Premarket Exempt : Yes

Product Code : KMK

Prescription Use : Yes

Device Count : 1

Clik-FIX - 00850933007016 Catalog Number : PCS-1011

Device Description : Clik-FIX All 'n One Peripheral IV Securement

Device Class :

Duns Number: 012983893

Premarket Exempt : Yes

Product Code : KMK

Prescription Use : Yes

Device Count : 1

Starboard Temperature Probes - 00850933007023 Catalog Number : 4009-ES

Device Description : Esophageal Stethoscope with 400 Series Temperature Sensor, 9 Fr.

Device Class : 2

Duns Number: 012983893

Premarket Exempt : No

Product Code : BZT

Prescription Use : Yes

Device Count : 1

Starboard Temperature Probes - 00850933007030 Catalog Number : 40012-ES

Device Description : Esophageal Stethoscope with 400 Series Temperature Sensor, 12 Fr.

Device Class : 2

Duns Number: 012983893

Premarket Exempt : No

Product Code : BZT

Prescription Use : Yes

Device Count : 1

Starboard Temperature Probes - 00850933007047 Catalog Number : 40018-ES

Device Description : Esophageal Stethoscope with 400 Series Temperature Sensor, 18 Fr.

Device Class : 2

Duns Number: 012983893

Premarket Exempt : No

Product Code : BZT

Prescription Use : Yes

Device Count : 1

Starboard Temperature Probes - 00850933007054 Catalog Number : 40024-ES

Device Description : Esophageal Stethoscope with 400 Series Temperature Sensor, 24 Fr.

Device Class : 2

Duns Number: 012983893

Premarket Exempt : No

Product Code : BZT

Prescription Use : Yes

Device Count : 1

Starboard Temperature Probes - 00850933007061 Catalog Number : 4009-ER

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

Device Class : 2

Duns Number: 012983893

Premarket Exempt : No

Product Code : BZT

Prescription Use : Yes

Device Count : 1

Starboard Temperature Probes - 00850933007078 Catalog Number : 40012-ER

Device Description : Esophageal/Rectal General Purpose 400 Series Temperature Sensor,12 Fr.

Device Class : 2

Duns Number: 012983893

Premarket Exempt : No

Product Code : BZT

Prescription Use : Yes

Device Count : 1

Starboard Temperature Probes - 00850933007085 Catalog Number : 400-SK

Device Description : Skin Temperature Sensor (400 Series Thermistor)

Device Class : 2

Duns Number: 012983893

Premarket Exempt : No

Product Code : FLL

Prescription Use : Yes

Device Count : 1

Starboard Temperature Probes - 00850933007092 Catalog Number : 400-TY

Device Description : Adult Tympanic Temperature Sensor (400 Series Thermistor)

Device Class : 2

Duns Number: 012983893

Premarket Exempt : No

Product Code : FLL

Prescription Use : Yes

Device Count : 1

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