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

DETECTOR AND ALARM, ARRHYTHMIA (DSI) (8) RECORDER, PAPER CHART (DSF) (1) Thermometer, electronic, clinical (FLL) (1)

Premarket Exempt

No Yes

Clear

Temperature Probes - 00884838001015 Catalog Number : 21078A

Device Description : Skin Surface Temperature Probe Reusable; stainless steel disc; epoxy backing; si Skin Surface Temperature Probe Reusable; stainless steel disc; epoxy backing; size = 3/8" (9.5mm); length = 10' (3.1m); wgt = 1 lb (454g)

Device Class : 2

Duns Number: 790605856

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Paper - 00884838001121 Catalog Number : 989803101501

Device Class : 1

Duns Number: 790605856

Premarket Exempt : Yes

Product Code : DSF

Prescription Use : No

Device Count : 1

NIBP Cuffs - 00884838001541 Catalog Number : M1571A

Device Description : Long-life reusable NIBP cuff/infant Premium quality individual cuff w/fluid cap Long-life reusable NIBP cuff/infant Premium quality individual cuff w/fluid cap & instructions; limb circumference 12.0-17.5cm. Polyurethane bladder, hose, cover. No latex or PVC. wt=.025lb

Device Class : 2

Duns Number: 790605856

Premarket Exempt : No

Product Code : DSI

Prescription Use : No

Device Count : 1

NIBP Cuffs - 00884838001558 Catalog Number : M1572A

Device Description : Long-life reusable NIBP cuff/pediatric. Premium quality individual cuff w/fluid Long-life reusable NIBP cuff/pediatric. Premium quality individual cuff w/fluid cap and instructions. For limb circumference 17-24cm. Polyurethane bladder, hose, cover. No latex or PVC.

Device Class : 2

Duns Number: 790605856

Premarket Exempt : No

Product Code : DSI

Prescription Use : No

Device Count : 1

NIBP Cuffs - 00884838001565 Catalog Number : M1573A

Device Description : Long-life reusable NIBP cuff/small adult Premium quality individual cuff w/fluid Long-life reusable NIBP cuff/small adult Premium quality individual cuff w/fluid cap and instructions. For limb circumference 22-32cm. Polyurethane bladder, hose, cover. No latex or PVC.

Device Class : 2

Duns Number: 790605856

Premarket Exempt : No

Product Code : DSI

Prescription Use : No

Device Count : 1

NIBP Cuffs - 00884838001572 Catalog Number : M1574A

Device Description : Long-life reusable NIBP cuff/adult. Premium quality individual cuff w/fluid cap Long-life reusable NIBP cuff/adult. Premium quality individual cuff w/fluid cap and instructions. For limb circum-ference 27.0-37.5cm. Polyurethane bladder, hose, cover. No latex or PVC.

Device Class : 2

Duns Number: 790605856

Premarket Exempt : No

Product Code : DSI

Prescription Use : No

Device Count : 1

NIBP Cuffs - 00884838001589 Catalog Number : M1575A

Device Description : Long-life reusable NIBP cuff/large adult Premium quality individual cuff w/fluid Long-life reusable NIBP cuff/large adult Premium quality individual cuff w/fluid cap and instructions. For limb circumference 37-51 cm. Polyurethane bladder, hose, cover. No latex or PVC.

Device Class : 2

Duns Number: 790605856

Premarket Exempt : No

Product Code : DSI

Prescription Use : No

Device Count : 1

NIBP Cuffs - 00884838001596 Catalog Number : M1576A

Device Description : Long-life reusable NIBP cuff/thigh. Premium quality individual cuff w/fluid cap Long-life reusable NIBP cuff/thigh. Premium quality individual cuff w/fluid cap and instructions. For limb circumference 45-60cm. Polyurethane bladder, hose, cover. No latex or PVC.

Device Class : 2

Duns Number: 790605856

Premarket Exempt : No

Product Code : DSI

Prescription Use : No

Device Count : 1

NA - 00884838001602 Catalog Number : 989803104201

Device Class : 2

Duns Number: 790605856

Premarket Exempt : No

Product Code : DSI

Prescription Use : No

Device Count : 1

NA - 00884838001619 Catalog Number : 989803104211

Device Class : 2

Duns Number: 790605856

Premarket Exempt : No

Product Code : DSI

Prescription Use : No

Device Count : 1

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