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

TUBING, PRESSURE AND ACCESSORIES (BYX) (4) CANNULA, NASAL, OXYGEN (CAT) (2) NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER) (CCQ) (2) HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) (BTT) (1) Monitor, breathing frequency (BZQ) (1)

Premarket Exempt

No Yes

Clear

N/A - 00607411000737 Catalog Number : 8900-14

Device Description : Full Kit Nebulizer Set with mouthpiece, tee adaptor, reservoir, 14’ (4.3 m) supply tube

Device Class : 1

Duns Number: 022721133

Premarket Exempt : No

Product Code : CCQ

Prescription Use : Yes

Device Count : 1

n/a - 00607411000799 Catalog Number : SO-1594-0

Device Description : PATIENT KIT

Device Class : 1

Duns Number: 022721133

Premarket Exempt : Yes

Product Code : CAT

Prescription Use : Yes

Device Count : 1

N/A - 00607411000843 Catalog Number : M128583

Device Description : Salter Oxygen Tubing Connector

Device Class : 1

Duns Number: 022721133

Premarket Exempt : Yes

Product Code : BYX

Prescription Use : Yes

Device Count : 1

N/A - 00607411000881 Catalog Number : 5006-1

Device Description : Adult Oral/Nasal Pressure Monitoring Cannula with 1' (0.3 m) tube with male Luer Adult Oral/Nasal Pressure Monitoring Cannula with 1' (0.3 m) tube with male Luer-lock connection.

Device Class : 2

Duns Number: 022721133

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

N/A - 00607411000898 Catalog Number : E7900-0

Device Description : Bubble Humidifier (6-15 LPM) with 6 PSI safety valve

Device Class :

Duns Number: 022721133

Premarket Exempt : No

Product Code : BTT

Prescription Use : Yes

Device Count : 1

N/A - 00607411000928 Catalog Number : 1020-0

Device Description : Adaptor- 22 mm I.D. x 6 mm O.D. Single Patient use. Do not sterilize.

Device Class : 1

Duns Number: 022721133

Premarket Exempt : Yes

Product Code : BYX

Prescription Use : Yes

Device Count : 1

n/a - 00607411000966 Catalog Number : 7001-0

Device Description : Water Trap

Device Class : 1

Duns Number: 022721133

Premarket Exempt : Yes

Product Code : BYX

Prescription Use : Yes

Device Count : 1

N/A - 00607411000980 Catalog Number : 1001-0-25

Device Description : Filter

Device Class : 1

Duns Number: 022721133

Premarket Exempt : Yes

Product Code : BYX

Prescription Use : Yes

Device Count : 1

N/A - 00607411000997 Catalog Number : M127898-0

Device Description : Nasal Cannula (adult) Salter Style®with 4' (1.2 m) supply tube, “micro” cannula Nasal Cannula (adult) Salter Style®with 4' (1.2 m) supply tube, “micro” cannula for flows up to 3 LPM.

Device Class : 1

Duns Number: 022721133

Premarket Exempt : Yes

Product Code : CAT

Prescription Use : Yes

Device Count : 1

N/A - 00607411001017 Catalog Number : 1003-0-50

Device Description : Mouthpiece (22 mm)

Device Class : 1

Duns Number: 022721133

Premarket Exempt : No

Product Code : CCQ

Prescription Use : Yes

Device Count : 1

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