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

Bed, Ac-Powered Adjustable Hospital (FNL) (8) Mattress, Air Flotation, Alternating Pressure (FNM) (1) Oximeter (DQA) (1)

Premarket Exempt

Yes No

Clear

PMI Probasics® Satin Air™ - 00841447104117 Catalog Number : APMBARI48

Device Description : Satin Air Bariatric APM 48"

Device Class : 2

Duns Number: 005249268

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

PMI Probasics® - 00841447104124 Catalog Number : HBSMX

Device Description : Single Motor Semi-Electric Home Care Bed

Device Class : 2

Duns Number: 005249268

Premarket Exempt : Yes

Product Code : FNL

Prescription Use : No

Device Count : 1

PMI Probasics® - 00841447104131 Catalog Number : 5201

Device Description : Bed Ends - Replacement parts for HBSM

Device Class : 2

Duns Number: 005249268

Premarket Exempt : Yes

Product Code : FNL

Prescription Use : No

Device Count : 1

PMI Probasics® - 00841447104148 Catalog Number : 5301

Device Description : Bed Ends - Replacement parts for HBSM

Device Class : 2

Duns Number: 005249268

Premarket Exempt : Yes

Product Code : FNL

Prescription Use : No

Device Count : 1

PMI Probasics® - 00841447104155 Catalog Number : 5501

Device Description : Low Bed Ends Only

Device Class : 2

Duns Number: 005249268

Premarket Exempt : Yes

Product Code : FNL

Prescription Use : No

Device Count : 1

PMI Probasics® - 00841447104179 Catalog Number : HB4M

Device Description : Bariatric Bed

Device Class : 2

Duns Number: 005249268

Premarket Exempt : Yes

Product Code : FNL

Prescription Use : No

Device Count : 1

PMI Probasics® - 00841447104186 Catalog Number : HB6M

Device Description : Bariatric Bed

Device Class : 2

Duns Number: 005249268

Premarket Exempt : Yes

Product Code : FNL

Prescription Use : No

Device Count : 1

PMI Probasics® - 00841447104193 Catalog Number : 3301

Device Description : Bed Ends for HB4 Bariatric Bed

Device Class : 2

Duns Number: 005249268

Premarket Exempt : Yes

Product Code : FNL

Prescription Use : No

Device Count : 1

PMI Probasics® - 00841447104209 Catalog Number : HB5LBX

Device Description : Full Electric Low Bed

Device Class : 2

Duns Number: 005249268

Premarket Exempt : Yes

Product Code : FNL

Prescription Use : No

Device Count : 1

PMI Probasics® - 00841447104216 Catalog Number : 8610

Device Description : Digit-Ox II Portable Finger Pulse Oximeter

Device Class : 2

Duns Number: 005249268

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

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