SMD Manufacturing LLC

Address:918 S 500 W STE A,Salt Lake City,UT,84101,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

Device, Intravascular Catheter Securement (KMK) (3) Applicator, Absorbent Tipped, Non-Sterile (KXF) (2) Catheter And Tip, Suction (JOL) (2) Toothbrush, Manual (EFW) (1) Ventilator, Continuous, Non-Life-Supporting (MNS) (1)

Premarket Exempt

No Yes

Clear

ReddyPort - 00850001175005 Catalog Number :

Device Description : Multi-functional NIV elbow for Philips Respironics 531 and Performax Masks, Leak 1

Device Class :

Duns Number: 070849038

Premarket Exempt : No

Product Code : MNS

Prescription Use : Yes

Device Count : 1

Moisturizer - 00850001175203 Catalog Number :

Device Description : ReddyPort Moisturizer Pack for use with ReddyPort Elbow. Moisturizer Pack inclu ReddyPort Moisturizer Pack for use with ReddyPort Elbow. Moisturizer Pack includes: 1x suction swab, 1x mouth moisturizer, 1x applicator swab

Device Class : 1

Duns Number: 070849038

Premarket Exempt : Yes

Product Code : JOL, KXF

Prescription Use : Yes

Device Count : 1

ReddyPort - 00850001175210 Catalog Number :

Device Description : 24 hour maintenance kit for oral care with ReddyPort Elbow. 24 hour maintenance 24 hour maintenance kit for oral care with ReddyPort Elbow. 24 hour maintenance kit includes: 1x prep pack (yankauer), 2x suction silicone toothbrush packs with anti-plaque solution (cetylpyridinium chloride 0.05%), applicator swabs and mouth moisturizer, 4x suction swab packs with suction swab, applicator swab, antiseptic oral rinse (hydrogen peroxide 1.5%) and mouth moisturizer.

Device Class :

Duns Number: 070849038

Premarket Exempt : Yes

Product Code : KXF, JOL, EFW

Prescription Use : Yes

Device Count : 1

LineLogic™ - 00851780008003 Catalog Number :

Device Description : Sterile, Linelogic™ 6 Fr Catheter Stabilization Device

Device Class :

Duns Number: 070849038

Premarket Exempt : Yes

Product Code : KMK

Prescription Use : No

Device Count : 1

LineLogic™ - 00851780008102 Catalog Number :

Device Description : Sterile, Linelogic™ 7 Fr Catheter Stabilization Device

Device Class :

Duns Number: 070849038

Premarket Exempt : Yes

Product Code : KMK

Prescription Use : No

Device Count : 1

LineLogic™ - 00851780008201 Catalog Number :

Device Description : Sterile, Linelogic™ 8.5 Fr Catheter Stabilization Device

Device Class :

Duns Number: 070849038

Premarket Exempt : Yes

Product Code : KMK

Prescription Use : No

Device Count : 1

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