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

Yes No

Clear

NIBP Cuffs - 00884838003125 Catalog Number : M4556B

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

Device Class : 2

Duns Number: 790605856

Premarket Exempt : No

Product Code : OED

Prescription Use : No

Device Count : 1

NIBP Cuffs - 00884838003156 Catalog Number : M4557B

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

Device Class : 2

Duns Number: 790605856

Premarket Exempt : No

Product Code : OED

Prescription Use : No

Device Count : 1

NIBP Cuffs - 00884838003187 Catalog Number : M4558B

Device Description : Antimicrobial NIBP Cuff, Reusable, Single Hose, Large Adult X-Long (1)

Device Class : 2

Duns Number: 790605856

Premarket Exempt : No

Product Code : OED

Prescription Use : No

Device Count : 1

NIBP Cuffs - 00884838003217 Catalog Number : M4559B

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

Device Class : 2

Duns Number: 790605856

Premarket Exempt : No

Product Code : OED

Prescription Use : No

Device Count : 1

HS Switchless Internal Paddle Adapter - 00884838003316 Catalog Number : 989803109721

Device Class : 3

Duns Number: 790605856

Premarket Exempt : No

Product Code : MKJ

Prescription Use : No

Device Count : 1

NA - 00884838003323 Catalog Number : M4741A

Device Description : Extra Large Switched Internal Paddles

Device Class : 3

Duns Number: 790605856

Premarket Exempt : No

Product Code : MKJ

Prescription Use : No

Device Count : 1

NA - 00884838003330 Catalog Number : M4742A

Device Description : Large Switched Internal Paddles

Device Class : 3

Duns Number: 790605856

Premarket Exempt : No

Product Code : MKJ

Prescription Use : No

Device Count : 1

NA - 00884838003347 Catalog Number : M4743A

Device Description : Medium Switched Internal Paddles

Device Class : 3

Duns Number: 790605856

Premarket Exempt : No

Product Code : MKJ

Prescription Use : No

Device Count : 1

NA - 00884838003354 Catalog Number : M4744A

Device Description : Small Switched Internal Paddles

Device Class : 3

Duns Number: 790605856

Premarket Exempt : No

Product Code : MKJ

Prescription Use : No

Device Count : 1

NA - 00884838003361 Catalog Number : M4746A

Device Description : External Paddles with PCI

Device Class : 3

Duns Number: 790605856

Premarket Exempt : No

Product Code : MKJ

Prescription Use : No

Device Count : 1

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