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

Device, Transfer, Patient, Manual (FMR) (5) Cable, Electrode (IKD) (2) Fall Prevention Alarm/Sensor Combination Attached Or Unattached (PJO) (2) Monitor, Bed Patient (KMI) (1)

Premarket Exempt

No Yes

Clear

AirPal Repositioning Sheet - 00816317023911 Catalog Number :

Device Description : NOVAPLUS Disposable Transfer Pad, 34" W x 78" L

Device Class : 1

Duns Number: 100439103

Premarket Exempt : Yes

Product Code : FMR

Prescription Use : No

Device Count : 1

AirPal Repositioning Sheet - 00816317023928 Catalog Number :

Device Description : NOVAPLUS Disposable Short Transfer Pad, 34" W x 47" LX

Device Class : 1

Duns Number: 100439103

Premarket Exempt : Yes

Product Code : FMR

Prescription Use : No

Device Count : 1

AirPal Repositioning Sheet - 00816317023935 Catalog Number :

Device Description : NOVAPLUS Disposable Transfer Pad, 39" W x 78" L

Device Class : 1

Duns Number: 100439103

Premarket Exempt : Yes

Product Code : FMR

Prescription Use : No

Device Count : 1

AirPal Repositioning Sheet - 00816317023942 Catalog Number :

Device Description : NOVAPLUS Disposable Short Transfer Pad, 39" W x 47" L

Device Class : 1

Duns Number: 100439103

Premarket Exempt : Yes

Product Code : FMR

Prescription Use : No

Device Count : 1

AirPal Repositioning Sheet - 00816317023959 Catalog Number :

Device Description : NOVAPLUS Disposable Transfer Pad, 50" W x 78" L

Device Class : 1

Duns Number: 100439103

Premarket Exempt : Yes

Product Code : FMR

Prescription Use : No

Device Count : 1

Draeger 5-Lead ECG - Reprocessed - 00816317023966 Catalog Number :

Device Description : ECG Cable, 5-Lead, Single Patient Use, IEC2

Device Class : 2

Duns Number: 100439103

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

Philips - 00816317024017 Catalog Number :

Device Description : ECG Cable, 5-Lead, Grabbers, Single Patient Use, 85cm

Device Class : 2

Duns Number: 100439103

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

Stanley Healthcare - 00816317024024 Catalog Number :

Device Description : Bed-Check ST Chair Sensormat

Device Class : 1

Duns Number: 100439103

Premarket Exempt : Yes

Product Code : KMI

Prescription Use : Yes

Device Count : 1

Posey - 00816317024031 Catalog Number :

Device Description : Chair Sensor Pad 8309

Device Class : 1

Duns Number: 100439103

Premarket Exempt : Yes

Product Code : PJO

Prescription Use : Yes

Device Count : 1

Posey - 00816317024048 Catalog Number :

Device Description : Chair Sensor Pad 8309EL

Device Class : 1

Duns Number: 100439103

Premarket Exempt : Yes

Product Code : PJO

Prescription Use : Yes

Device Count : 1

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