PMI

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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

Mattress, Air Flotation, Alternating Pressure (FNM) (5) Nebulizer (Direct Patient Interface) (CAF) (5)

Premarket Exempt

No Yes

Clear

PMI Probasics® - 00841447104018 Catalog Number : 8005LP3

Device Description : Probasics Rite-Neb3 Mini Compressor Nebulizer

Device Class :

Duns Number: 005249268

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

PMI Probasics® - 00841447104025 Catalog Number : 8005SP

Device Description : Probasics Rite-Neb 4™ Nebulizer Compressor

Device Class :

Duns Number: 005249268

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

PMI Probasics® - 00841447104032 Catalog Number : 8012

Device Description : Humphrey the Hippo Pediatric Nebulizer

Device Class : 2

Duns Number: 005249268

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

PMI Probasics® - 00841447104049 Catalog Number : 8011

Device Description : Buddy the Dog Pediatric Compressor Nebulizer

Device Class : 2

Duns Number: 005249268

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

PMI Probasics® - 00841447104056 Catalog Number : 8025

Device Description : Reusable Jet Nebulizer Set

Device Class : 2

Duns Number: 005249268

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

PMI Probasics® Satin Air™ - 00841447104063 Catalog Number : SA850K

Device Description : Alternating Pressure Pump and Pad Set

Device Class : 2

Duns Number: 005249268

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

PMI Probasics® - 00841447104070 Catalog Number : SA901P

Device Description : APP (Pads only)

Device Class : 2

Duns Number: 005249268

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

PMI Probasics® Satin Air™ - 00841447104087 Catalog Number : MER-SAPM2

Device Description : Pump and Mattress – Low Air Loss System

Device Class : 2

Duns Number: 005249268

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

PMI Probasics® Satin Air™ - 00841447104094 Catalog Number : SATINAPMDLX

Device Description : Deluxe 8" APM Low Air Loss (34x80)

Device Class : 2

Duns Number: 005249268

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

PMI Probasics® Satin Air™ - 00841447104100 Catalog Number : PBAPMBARI42

Device Description : ProBasics Satin Air Bariatric APM 42"

Device Class : 2

Duns Number: 005249268

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

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