Philips Medical Systems Hsg

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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

Automated External Defibrillators (Non-Wearable) (MKJ) (5) Antimicrobial blood pressure cuff (OED) (4) Automated external defibrillators (non-wearable) (MKJ) (1)

Premarket Exempt

No Yes

Clear

HeartStart MRx Lithium Ion Module (Rechargeable) - 00884838002791 Catalog Number : 989803129011

Device Class : 3

Duns Number: 790605856

Premarket Exempt : No

Product Code : MKJ

Prescription Use : No

Device Count : 1

HeartStart Adult/Child Plus Pads - 00884838002845 Catalog Number : M3713A

Device Description : HeartStart Adult/Child Plus Pads

Device Class : 3

Duns Number: 790605856

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

NA - 00884838002852 Catalog Number : M3716A

Device Description : HeartStream Adult/Child Radiolucent Pads

Device Class : 3

Duns Number: 790605856

Premarket Exempt : No

Product Code : MKJ

Prescription Use : No

Device Count : 1

HeartStart - 00884838002869 Catalog Number : M3717A

Device Description : HeartStart Infant Plus Pads

Device Class : 3

Duns Number: 790605856

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

HeartStart Pads - 00884838002876 Catalog Number : M3718A

Device Description : HeartStart Adult Radiotransparent Pads

Device Class : 3

Duns Number: 790605856

Premarket Exempt : No

Product Code : MKJ

Prescription Use : No

Device Count : 1

HeartStart Pads - 00884838002883 Catalog Number : M3719A

Device Description : HS Pedi Radiotransparent Pads

Device Class : 3

Duns Number: 790605856

Premarket Exempt : No

Product Code : MKJ

Prescription Use : No

Device Count : 1

NIBP Cuffs - 00884838002999 Catalog Number : M4552B

Device Description : Antimicrobial NIBP Cuff, Reusable, Single Hose, Infant (1)

Device Class : 2

Duns Number: 790605856

Premarket Exempt : No

Product Code : OED

Prescription Use : No

Device Count : 1

NIBP Cuffs - 00884838003026 Catalog Number : M4553B

Device Description : Antimicrobial NIBP Cuff, Reusable, Single Hose, Pediatric (1)

Device Class : 2

Duns Number: 790605856

Premarket Exempt : No

Product Code : OED

Prescription Use : No

Device Count : 1

NIBP Cuffs - 00884838003057 Catalog Number : M4554B

Device Description : Antimicrobial NIBP Cuff, Reusable, Single Hose, Small Adult (1)

Device Class : 2

Duns Number: 790605856

Premarket Exempt : No

Product Code : OED

Prescription Use : No

Device Count : 1

NIBP Cuffs - 00884838003095 Catalog Number : M4555B

Device Description : Antimicrobial NIBP Cuff, Reusable, Single Hose, Adult (1)

Device Class : 2

Duns Number: 790605856

Premarket Exempt : No

Product Code : OED

Prescription Use : No

Device Count : 1

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