RPI

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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

Cable, Transducer And Electrode, Patient, (Including Connector) (DSA) (4) Unit, Neonatal Phototherapy (LBI) (2)

Premarket Exempt

Clear

SKIN TEMP PROBE - 50 - 00841034117308 Catalog Number : OMP010

Device Class :

Duns Number: 066232067

Premarket Exempt : No

Product Code : DSA

Prescription Use : No

Device Count : 50

SKIN TEMP PROBE (REUSABLE) - 00841034117315 Catalog Number : OMP011

Device Class : 2

Duns Number: 066232067

Premarket Exempt : No

Product Code : DSA

Prescription Use : No

Device Count : 1

SKIN TEMP PROBE (REUSABLE) - 00841034117322 Catalog Number : OMP012

Device Class : 2

Duns Number: 066232067

Premarket Exempt : No

Product Code : DSA

Prescription Use : No

Device Count : 1

COMPARTMENT AIR PROBE - 00841034117339 Catalog Number : OMP018

Device Class : 2

Duns Number: 066232067

Premarket Exempt : No

Product Code : DSA

Prescription Use : No

Device Count : 1

LAMP (12VDC 100W) - 6 - 00841034134572 Catalog Number : LMP028

Device Description : BULB ONLY

Device Class :

Duns Number: 066232067

Premarket Exempt : No

Product Code : LBI

Prescription Use : No

Device Count : 6

LAMP (52VDC 50W) - 00841034134589 Catalog Number : LMP029

Device Description : BULB ONLY

Device Class : 2

Duns Number: 066232067

Premarket Exempt : No

Product Code : LBI

Prescription Use : No

Device Count : 1

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