SPAN-AMERICA MEDICAL SYSTEMS, INC.

Address:70 Commerce Ctr,GREENVILLE,SC,29615,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

Mattress, Air Flotation, Alternating Pressure (FNM) (6) Mattress, Flotation Therapy, Non-Powered (IKY) (4)

Premarket Exempt

Yes

Clear

PressureGuard® - H93315782 Catalog Number : 15782

Device Description : Alternating Pressure Mattress

Device Class : 2

Duns Number: 073704413

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

Span-America - H93316478 Catalog Number : 16478

Device Description : GM 350 75X35X5.5 W/RAISED PERIMETER

Device Class : 1

Duns Number: 073704413

Premarket Exempt : Yes

Product Code : IKY

Prescription Use : No

Device Count : 1

PressureGuard - H93316616 Catalog Number : 16616

Device Description : Alternating Pressure Mattress

Device Class : 2

Duns Number: 073704413

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

Span-America - H93316745 Catalog Number : 16745

Device Description : GM Max 78" x 33" x 6"

Device Class : 1

Duns Number: 073704413

Premarket Exempt : Yes

Product Code : IKY

Prescription Use : No

Device Count : 1

Span-America - H93316925 Catalog Number : 16925

Device Description : CUSTOM CARE NP 80 X 48 NO COVER

Device Class : 1

Duns Number: 073704413

Premarket Exempt : Yes

Product Code : IKY

Prescription Use : No

Device Count : 1

Span-America - H93316938 Catalog Number : 16938

Device Description : SPAN-CARE 80 X 35.5 NO COVER

Device Class : 2

Duns Number: 073704413

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

PressureGuard® - H93317536 Catalog Number : CL843629

Device Description : Alternating Pressure Mattress

Device Class : 2

Duns Number: 073704413

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

PressureGuard® - H93317641 Catalog Number : 17641

Device Description : Alternating Pressure Mattress

Device Class : 2

Duns Number: 073704413

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

Span-America - H93318025 Catalog Number : 18025

Device Description : APM2 BULLNOSE MATTRESS 78 X 34.5 X 7

Device Class : 2

Duns Number: 073704413

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

Span-America - H93318154 Catalog Number : 18154

Device Description : GM Plus 88x42x6 w/ Firm Perimeter

Device Class : 1

Duns Number: 073704413

Premarket Exempt : Yes

Product Code : IKY

Prescription Use : No

Device Count : 1

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