Prevantics Swab
Chlorhexidine Gluconate and Isopropyl Alcohol
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2411192 | 2411192 | PROFESSIONAL DISPOSABLES INTERNATIONAL, INC. | 1 | N | 2026-01-01 | 2 NICE PAK PARK ORANGEBURG NY US 10962 |
| 3015361761 | 3015361761 | PROFESSIONAL DISPOSABLES INTERNATIONAL, INC. | 1 | N | 2026-01-01 | 400 Chestnut Ridge Road Woodcliff Lake NJ US 07677 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00310819000031 | Prevantics® Device Large Swab - Pre-moistened swab to disinfect needleless access sites prior to use. | 800-999-6423 | pdicustomercare@pdihc.com |
| 00310819000307 | Hygea Sterile Saline Wipe - Wipe used for cleansing with a sterile saline solution where indicated | 800-999-6423 | pdicustomercare@pdihc.com |
| 00310819000451 | PDI® Adhesive Tape Remover Pad - To remove adhesive tape from skin. | 800-999-6423 | pdicustomercare@pdihc.com |
| 00310819000475 | PDI® Electrode Prep Pad - Pre-moistened pad used to remove surface skin oil and cleanse skin area in preparation for electrode placement. | 800-999-6423 | pdicustomercare@pdihc.com |
| 00310819000482 | PDI® Lubricating Jelly II - Lubricating jelly to lubricate the body orifices to facilitate the entry of medical and therapeutic devices. | 800-999-6423 | pdicustomercare@pdihc.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 6827 | 1837457853 | K974768 | PDI STERILE LUBRICATING JELLY | KMJ | 1998-01-16 |
| 230265 | 1837457853 | K974768 | PDI STERILE LUBRICATING JELLY | KMJ | 1998-01-16 |
| 6827 | 1073979594 | K132380 | PREVANTICS DEVICE SWAB | LKB | 2014-08-27 |
| 230265 | 1073979594 | K132380 | PREVANTICS DEVICE SWAB | LKB | 2014-08-27 |
| 6827 | 1029649680 | ||||
| 230265 | 1029649680 | ||||
| 6827 | 1650574568 | ||||
| 230265 | 1650574568 | ||||
| 6827 | 1937858236 | ||||
| 230265 | 1937858236 |
Chlorhexidine Gluconate and Isopropyl Alcohol
Chlorhexidine Gluconate and Isopropyl Alcohol
Povidone Iodine
Povidone-Iodine
providone iodine
providone iodine
Povidone Iodine USP, 10% w/w
Povidone Iodine USP, 10% w/w
Alcohol
Alcohol
chlorhexidine gluconate and isopropyl alcohol
chlorhexidine gluconate and isopropyl alcohol
Alcohol
Alcohol
Alcohol
Alcohol
PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.
2024-02-15
2020-10-09
2020-10-09
2020-08-03
2020-08-03
2020-08-03
2020-08-03
2020-08-03
2020-08-03
2020-08-03
2020-08-03
2020-08-03