Philips Medical Systems Hsg

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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

ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE (CCK) (5) CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR) (DSA) (4) TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY (DRG) (1)

Premarket Exempt

No Yes

Clear

ECG Electrodes - 20884838075737 Catalog Number : 989803174211

Device Description : 5-Lead Set, disposable, for single patient use, to measure bedside ECG. IEC colo 5-Lead Set, disposable, for single patient use, to measure bedside ECG. IEC color coded grabbers. Round (rd) peelable ribbon style wires. Wire length: 3,3ft (1m). For use with trunk cables: M1668A, M1663A and M1949A. 1 Sales Unit = 20 single wrapped lead sets

Device Class :

Duns Number: 790605856

Premarket Exempt : No

Product Code : DSA

Prescription Use : No

Device Count : 20

ECG Cables and Leadsets - 20884838075744 Catalog Number : 989803192141

Device Description : 5-Lead Set, disposable chest leads for single patient use, to measure 12-lead be 5-Lead Set, disposable chest leads for single patient use, to measure 12-lead bedside ECG. AAMI color coded grabbers. Round peelable ribbon style wires. Wirelength: 3.3ft (1m). For use with trunk cables: M1663A and M1949A when paired with 989803173131 (disposable limb leads). 1 Sales Unit = 20 individually packagedlead sets.

Device Class :

Duns Number: 790605856

Premarket Exempt : No

Product Code : DSA

Prescription Use : No

Device Count : 20

ECG Cables and Leadsets - 20884838075751 Catalog Number : 989803192151

Device Description : 5-Lead Set, disposable chest leads for single patient use, to measure 12-lead b 5-Lead Set, disposable chest leads for single patient use, to measure 12-lead bedside ECG.IEC color codedgrabbers. Round peelable ribbon style wires. Wire length: 3.3ft (1m). For use with trunk cables: M1663A and M1949A when paired with 989803174211 (disposable limb leads). 1 Sales Unit = 20 individually packaged lead sets.

Device Class :

Duns Number: 790605856

Premarket Exempt : No

Product Code : DSA

Prescription Use : No

Device Count : 20

Philips Wearable Biosensor - 20884838085231 Catalog Number : 989803200061

Device Class : 2

Duns Number: 790605856

Premarket Exempt : No

Product Code : DRG

Prescription Use : No

Device Count : 1

Philips - 20884838086832 Catalog Number : 989803166031

Device Description : Universal Clear Tab/Snap Adapter to Cardiograph Lead. Enables the connection fro Universal Clear Tab/Snap Adapter to Cardiograph Lead. Enables the connection from 3mm - 4mm post banana plug coming from the Cardiograph to tab & snap style electrodes. 1 bag = 10 adapters. Adapter can be sterilyzed by ethylene oxide - Not steam sterilizable. Adapters are for use with Philips PageWriter TC Series Cardiographs 860315 and 860310

Device Class : 2

Duns Number: 790605856

Premarket Exempt : No

Product Code : DSA

Prescription Use : Yes

Device Count : 1

Microstream Advance Adult Oral-Nasal CO2 Filter Line - 20884838091782 Catalog Number : 989803204551

Device Description : Microstream Advance Adult Oral-Nasal CO2 Filter Line

Device Class :

Duns Number: 790605856

Premarket Exempt : No

Product Code : CCK

Prescription Use : No

Device Count : 25

Microstream Advance Adult-Intermediate Bite Block CO2 Filter Line - 20884838091829 Catalog Number : 989803204461

Device Description : Microstream Advance Adult-Intermediate Bite Block CO2 Filter Line

Device Class :

Duns Number: 790605856

Premarket Exempt : No

Product Code : CCK

Prescription Use : No

Device Count : 25

Microstream Advance Adult-Pediatric Intubated CO2 Filter Line - 20884838091836 Catalog Number : 989803204521

Device Description : Adult-Pediatric Intubated CO2 Filter Line, Extended Duration

Device Class :

Duns Number: 790605856

Premarket Exempt : No

Product Code : CCK

Prescription Use : No

Device Count : 25

Microstream Advance Adult-Pediatric Intubated CO2 Filter Line - 20884838091850 Catalog Number : 989803204301

Device Description : Adult-Pediatric Intubated CO2 Filter Line, High Humidity

Device Class :

Duns Number: 790605856

Premarket Exempt : No

Product Code : CCK

Prescription Use : No

Device Count : 25

Microstream Advance Adult-Pediatric CO2 Intubated Filter Line - 20884838091867 Catalog Number : 989803204331

Device Description : Filterline Set

Device Class :

Duns Number: 790605856

Premarket Exempt : No

Product Code : CCK

Prescription Use : No

Device Count : 25

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