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

Prone Pillow - 00810044961010 Catalog Number : 803

Device Description : Prone Pillow 12" X 10" X 8"

Device Class : 1

Duns Number: 964459106

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Arm Board Pad / Utility Pad - 00810044961027 Catalog Number : 30-109-00

Device Description : Arm Board Pad / Utility Pad 10" X 24" X 2"

Device Class : 1

Duns Number: 964459106

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Arm Board Pad / Utility Pad - 00810044961034 Catalog Number : 30-110-00

Device Description : Arm Board Pad / Utility Pad 25" X 5" X 3"

Device Class : 1

Duns Number: 964459106

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Prone Positioning Pillow - 00810044961041 Catalog Number : 30-146-A

Device Description : P3 Adult 5" X 10-1/4" X 12"

Device Class : 1

Duns Number: 964459106

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Prone Positioning Pillow - 00810044961058 Catalog Number : 30-146-I

Device Description : P3 Infant 3-1/8" x 6-1/2" X 7-1/2"

Device Class : 1

Duns Number: 964459106

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Prone Positioning Pillow - 00810044961065 Catalog Number : 30-146-P

Device Description : P3 Pediatric 3-5/8" X 8" X 9-1/4"

Device Class : 1

Duns Number: 964459106

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

45 Degree Positioning Wedge - 00810044961072 Catalog Number : 30-209-00

Device Description : 45 Degree Positioning Wedge 26" X 18" X 18"

Device Class : 1

Duns Number: 964459106

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Positioning Wedge - 00810044961089 Catalog Number : 30-231-00

Device Description : Positioning Wedge 24" X 24" X 10.5"

Device Class : 1

Duns Number: 964459106

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Arterial Cannulation Supports - 00810044961096 Catalog Number : 30-777-00

Device Description : Standard Arterial Cannulation Support 9" X 3" X 2.75"

Device Class : 1

Duns Number: 964459106

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

Arterial Cannulation Supports - 00810044961102 Catalog Number : 30-777-DX

Device Description : Deluxe Arterial Cannulation Support 9" X 3" X 2.75"

Device Class : 1

Duns Number: 964459106

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : No

Device Count : 1

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