S.D.I. USA, INC.

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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

Bedding, Disposable, Medical (KME) (2) Nebulizer (Direct Patient Interface) (CAF) (2) Humidifier, Non-Direct Patient Interface (Home-Use) (KFZ) (1) System, Measurement, Blood-Pressure, Non-Invasive (DXN) (1) Thermometer, Electronic, Clinical (FLL) (1)

Premarket Exempt

No Yes

Clear

Clever Choice - 00850002860221 Catalog Number : 50002-0860-22

Device Description : Automatic Blood Pressure Monitor. Arm testing site. Also measures heart rate. Di Automatic Blood Pressure Monitor. Arm testing site. Also measures heart rate. Displays Blood Pressure reading as well as a World Health Organization rating of Blood Pressure readings, to easily indicate to user whether their blood pressure is too high or too low, and gives the user an idea of by how much.

Device Class : 2

Duns Number: 116722847

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Clever Choice - 00850002860238 Catalog Number :

Device Description : Ear & Forehead Thermometer - Infrared

Device Class : 2

Duns Number: 116722847

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Clever Choice Ultrasonic Humidifier - 00850002860245 Catalog Number : 50002-0860-24

Device Description : Clever Choice Ultrasonic Humidifier. 400ml / 13.5oz tank size. Measuring cup inc Clever Choice Ultrasonic Humidifier. 400ml / 13.5oz tank size. Measuring cup included. Timer function and low water auto-shutoff.

Device Class :

Duns Number: 116722847

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

Clever Choice Comfort Protect - 00850002860375 Catalog Number : 50002-0860-37

Device Description : Clever Choice Comfort Protect Adult Underpads - 30" x 36" 150 pack

Device Class :

Duns Number: 116722847

Premarket Exempt : Yes

Product Code : KME

Prescription Use : No

Device Count : 150

Clever Choice Comfort Protect - 00850002860429 Catalog Number : 50002-0860-42

Device Description : Clever Choice Comfort Protect Adult Underpads 30" x 36" 25 Pack

Device Class :

Duns Number: 116722847

Premarket Exempt : Yes

Product Code : KME

Prescription Use : No

Device Count : 25

Clever Choice - 00850002860481 Catalog Number :

Device Description : Clever Choice Universal Fit Reusable Nebulizer KitAdult SizeContains Nebulizer M Clever Choice Universal Fit Reusable Nebulizer KitAdult SizeContains Nebulizer Mask with elastic strap, Nebulizer Cup, 5 x Filters, Mouth Piece, and Air Tube with Connectors.

Device Class :

Duns Number: 116722847

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

Clever Choice - 00850002860498 Catalog Number :

Device Description : Clever Choice Universal Fit Reusable Nebulizer Kit - Child SizeContains Nebulize Clever Choice Universal Fit Reusable Nebulizer Kit - Child SizeContains Nebulizer Mask with elastic strap, Nebulizer Cup, 5 x Filters, Mouth Piece, and Air Tube with Connectors.

Device Class : 2

Duns Number: 116722847

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

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