SALTER LABS

Address:30 Spur Drive,El Paso,TX,79906,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

CANNULA, NASAL, OXYGEN (CAT) (3) Monitor, breathing frequency (BZQ) (3) HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) (BTT) (2) MASK, OXYGEN, LOW CONCENTRATION, VENTURI (BYF) (1) TUBING, PRESSURE AND ACCESSORIES (BYX) (1)

Premarket Exempt

No Yes

Clear

n/a - 00607411000355 Catalog Number : 8059-7

Device Description : Percent-O2-Lock® Assembly

Device Class : 1

Duns Number: 022721133

Premarket Exempt : Yes

Product Code : BYF

Prescription Use : Yes

Device Count : 1

n/a - 00607411000379 Catalog Number : SO-176

Device Description : Oxygen Tubing with 2 standard connectors (6 mm), 7’ (2.1 m) vinyl (DHD # 203-310 Oxygen Tubing with 2 standard connectors (6 mm), 7’ (2.1 m) vinyl (DHD # 203-310-016 Rev. E)

Device Class : 1

Duns Number: 022721133

Premarket Exempt : Yes

Product Code : BYX

Prescription Use : Yes

Device Count : 1

N/A - 00607411000386 Catalog Number : 1600HF-15

Device Description : Nasal Cannula (Adult) High Flow with 15’ (4.6 m) supply tube, for flows up to 15 LPM

Device Class : 1

Duns Number: 022721133

Premarket Exempt : Yes

Product Code : CAT

Prescription Use : Yes

Device Count : 1

n/a - 00607411000393 Catalog Number : SO-1570-0

Device Description : PATIENT KIT

Device Class : 1

Duns Number: 022721133

Premarket Exempt : Yes

Product Code : CAT

Prescription Use : Yes

Device Count : 1

N/A - 00607411000409 Catalog Number : SO-1394

Device Description : PATIENT KIT

Device Class : 2

Duns Number: 022721133

Premarket Exempt : Yes

Product Code : BTT

Prescription Use : Yes

Device Count : 1

ThermiSense - 00607411000416 Catalog Number : 5700EK-2-0

Device Description : ThermiSense® Oral/Nasal Thermal Air Flow Sensor for use with a PSG System. Reusable.

Device Class : 2

Duns Number: 022721133

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

ThermiSense - 00607411000430 Catalog Number : 5761-2

Device Description : ThermiSense® Oral/Nasal Air Flow Pressure Cannula (Adult) with Thermistor Holder ThermiSense® Oral/Nasal Air Flow Pressure Cannula (Adult) with Thermistor Holder, 2' (0.61 m) tube with male/female adaptor without filter

Device Class :

Duns Number: 022721133

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

n/a - 00607411000447 Catalog Number : SO-1571

Device Description : PATIENT KIT

Device Class : 1

Duns Number: 022721133

Premarket Exempt : Yes

Product Code : CAT

Prescription Use : Yes

Device Count : 1

ThermiSense - 00607411000454 Catalog Number : 5744-7-7

Device Description : ThermiSense® Oral/Nasal Air Flow Pressure and Gas Sampling Cannula (Adult) with ThermiSense® Oral/Nasal Air Flow Pressure and Gas Sampling Cannula (Adult) with Thermistor Holder 7’ (2.1 m) tubes with male/female connector for gas sampling and pressure monitoring.

Device Class :

Duns Number: 022721133

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

N/A - 00607411000461 Catalog Number : SO-1392-0

Device Description : PATIENT KIT

Device Class : 2

Duns Number: 022721133

Premarket Exempt : Yes

Product Code : BTT

Prescription Use : Yes

Device Count : 1

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