RENU MEDICAL, INC

Address:830 80th St SW, Suite 100,EVERETT,WA,98203,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

Tourniquet, Pneumatic (KCY) (5) Cable, Electrode (IKD) (3) Device, Transfer, Patient, Manual (FMR) (2)

Premarket Exempt

No Yes

Clear

Zimmer Tourniquet - 00816317023331 Catalog Number :

Device Description : Zimmer Tourniquet 30 inches

Device Class : 1

Duns Number: 100439103

Premarket Exempt : Yes

Product Code : KCY

Prescription Use : Yes

Device Count : 1

Zimmer Tourniquet - 00816317023348 Catalog Number :

Device Description : Zimmer Tourniquet 34 inch

Device Class :

Duns Number: 100439103

Premarket Exempt : Yes

Product Code : KCY

Prescription Use : Yes

Device Count : 1

Zimmer Tourniquet - 00816317023355 Catalog Number :

Device Description : Zimmer Tourniquet 42 inch

Device Class : 1

Duns Number: 100439103

Premarket Exempt : Yes

Product Code : KCY

Prescription Use : Yes

Device Count : 1

Advantage Medical Cable ECG Leads - 00816317023362 Catalog Number :

Device Description : AMC – Disp. 5 Lead Disposable Philips MX-40 Compatible Leadset

Device Class : 2

Duns Number: 100439103

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

Advantage Medical Cable ECG Leads - 00816317023379 Catalog Number :

Device Description : AMC - Disp. 6 Lead Grouped Set, Pinch to Molded Nihon Kohden

Device Class : 2

Duns Number: 100439103

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

Covidien ECG Leads - 00816317023386 Catalog Number :

Device Description : Covidien - DL Disp. Nihon Kohden 6 Lead Sys

Device Class :

Duns Number: 100439103

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

HoverMatt Lateral Transfer Mattress - 00816317023546 Catalog Number :

Device Description : HoverMatt Lateral Transfer Mattress HM34SPU-LNK-B

Device Class :

Duns Number: 100439103

Premarket Exempt : Yes

Product Code : FMR

Prescription Use : No

Device Count : 1

HoverMatt Lateral Transfer Mattress - 00816317023553 Catalog Number :

Device Description : HoverMatt Lateral Transfer Mattress HM39SPU-LNK-B

Device Class : 1

Duns Number: 100439103

Premarket Exempt : Yes

Product Code : FMR

Prescription Use : No

Device Count : 1

Zimmer Tourniquet - 00816317023560 Catalog Number :

Device Description : Zimmer Tourniquet 8 in. DPSB 60-7070-101-00

Device Class : 1

Duns Number: 100439103

Premarket Exempt : Yes

Product Code : KCY

Prescription Use : No

Device Count : 1

Zimmer Tourniquet - 00816317023577 Catalog Number :

Device Description : Zimmer Tourniquet 12 in. DPSB 60-7070-102-00

Device Class : 1

Duns Number: 100439103

Premarket Exempt : Yes

Product Code : KCY

Prescription Use : No

Device Count : 1

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