PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.

Address:400 Chestnut Ridge Road,Woodcliff Lake,NJ,07677,US

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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

Lubricant, Patient (KMJ) (2) Pad, Alcohol, Device Disinfectant (LKB) (2) Degreaser, Skin, Surgical (KOY) (1) Fiber, Medical, Absorbent (FRL) (1) Solvent, Adhesive Tape (KOX) (1)

Premarket Exempt

No Yes

Clear

Hygea Sterile Saline Wipe - 00310819000307 Catalog Number : C22370

Device Description : Wipe used for cleansing with a sterile saline solution where indicated

Device Class : 1

Duns Number: 800777117

Premarket Exempt : Yes

Product Code : FRL

Prescription Use : No

Device Count : 1

PDI® Adhesive Tape Remover Pad - 00310819000451 Catalog Number : B16400

Device Description : To remove adhesive tape from skin.

Device Class : 1

Duns Number: 800777117

Premarket Exempt : Yes

Product Code : KOX

Prescription Use : No

Device Count : 1

PDI® Electrode Prep Pad - 00310819000475 Catalog Number : B59800

Device Description : Pre-moistened pad used to remove surface skin oil and cleanse skin area in prepa Pre-moistened pad used to remove surface skin oil and cleanse skin area in preparation for electrode placement.

Device Class : 1

Duns Number: 800777117

Premarket Exempt : Yes

Product Code : KOY

Prescription Use : No

Device Count : 1

PDI® Lubricating Jelly II - 00310819000482 Catalog Number : T00137

Device Description : Lubricating jelly to lubricate the body orifices to facilitate the entry of medi Lubricating jelly to lubricate the body orifices to facilitate the entry of medical and therapeutic devices.

Device Class :

Duns Number: 800777117

Premarket Exempt : Yes

Product Code : KMJ

Prescription Use : No

Device Count : 1

PDI® Lubricating Jelly II - 00310819000499 Catalog Number : T00250

Device Class :

Duns Number: 800777117

Premarket Exempt : Yes

Product Code : KMJ

Prescription Use : No

Device Count : 1

Prevantics® Device Swab - 00310819001526 Catalog Number : B19600

Device Description : Pre-moistened swab to disinfect needleless access sites prior to use.

Device Class : U

Duns Number: 800777117

Premarket Exempt : No

Product Code : LKB

Prescription Use : No

Device Count : 1

Prevantics® Device Swab Strip - 00310819001779 Catalog Number : B123ST

Device Description : Pre-moistened swabs to disinfect needleless access sites prior to use. Strip of 8 swabs.

Device Class :

Duns Number: 800777117

Premarket Exempt : No

Product Code : LKB

Prescription Use : No

Device Count : 1

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