GENEVA HEALTHCARE, LLC

Address:826 Mohr Ave.,Waterford,WI,53185,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

Support, Patient Position (CCX) (10)

Premarket Exempt

Yes

Clear

Head Positioners - 00810044960501 Catalog Number : 30-104-P

Device Description : Pediatric Prone Concave Head Positioner 8" X 6.25" X 3.5"

Device Class : 1

Duns Number: 964459106

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Foam Mattress Pads - 00810044960518 Catalog Number : CM-43273D

Device Description : Convolute Mattress Topper 32" X 73" X 4"/4.5" Set

Device Class : 1

Duns Number: 964459106

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Foam Mattress Pads - 00810044960525 Catalog Number : CM-43273BO

Device Description : Convolute Mattress Topper 32" X 73" X 4"/5" Set

Device Class : 1

Duns Number: 964459106

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Foam Mattress Pads - 00810044960532 Catalog Number : CM-33273

Device Description : Convolute Mattress Topper 32" X 73" X 3"/3.5" Set

Device Class : 1

Duns Number: 964459106

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Sewn Tubular Foam Rolls - 00810044960587 Catalog Number : 40-100-00

Device Description : Sewn Tubular Foam Roll 2" X 72"

Device Class : 1

Duns Number: 964459106

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Foam Mattress Pads - 00810044960600 Catalog Number : CM-47680D

Device Description : KING Convolute Mattress Topper 4" X 76" X 80" Density # 1.2

Device Class : 1

Duns Number: 964459106

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Foam Mattress Pads - 00810044960617 Catalog Number : CM-47284D

Device Description : CALIFORNIA KING Convolute Mattress Topper 4" x 72" x 84"

Device Class : 1

Duns Number: 964459106

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Foam Mattress Pads - 00810044960624 Catalog Number : CM-47272D

Device Description : Convolute Mattress Topper 4" X 72" X 72" Density # 1.2

Device Class : 1

Duns Number: 964459106

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Foam Mattress Pads - 00810044960631 Catalog Number : CM-46080D

Device Description : QUEEN Convolute Mattress Topper 4" X 60" X 80" Density # 1.2

Device Class : 1

Duns Number: 964459106

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Foam Mattress Pads - 00810044960648 Catalog Number : CM-45672D

Device Description : Convolute Mattress Topper 4" X 56" X 72" Density # 1.2

Device Class : 1

Duns Number: 964459106

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

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