| Primary Device ID | 10310819001523 | 
| NIH Device Record Key | 50d1a2cf-7f99-4e0f-beac-beb21966d74f | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Prevantics® Device Swab | 
| Version Model Number | B19600 | 
| Catalog Number | B19600 | 
| Company DUNS | 800777117 | 
| Company Name | PROFESSIONAL DISPOSABLES INTERNATIONAL, INC. | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | false | 
| MRI Safety Status | Labeling does not contain MRI Safety Information | 
| Human Cell/Tissue Product | false | 
| Device Kit | false | 
| Device Combination Product | false | 
| Single Use | true | 
| Lot Batch | false | 
| Serial Number | false | 
| Manufacturing Date | false | 
| Expiration Date | false | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | false | 
| OTC Over-The-Counter | false | 
| Phone | 800-999-6423 | 
| pdicustomercare@pdihc.com | |
| Phone | 800-999-6423 | 
| pdicustomercare@pdihc.com | |
| Phone | 800-999-6423 | 
| pdicustomercare@pdihc.com | |
| Phone | 800-999-6423 | 
| pdicustomercare@pdihc.com | |
| Phone | 800-999-6423 | 
| pdicustomercare@pdihc.com | |
| Phone | 800-999-6423 | 
| pdicustomercare@pdihc.com | |
| Phone | 800-999-6423 | 
| pdicustomercare@pdihc.com | |
| Phone | 800-999-6423 | 
| pdicustomercare@pdihc.com | |
| Phone | 800-999-6423 | 
| pdicustomercare@pdihc.com | |
| Phone | 800-999-6423 | 
| pdicustomercare@pdihc.com | |
| Phone | 800-999-6423 | 
| pdicustomercare@pdihc.com | |
| Phone | 800-999-6423 | 
| pdicustomercare@pdihc.com | |
| Phone | 800-999-6423 | 
| pdicustomercare@pdihc.com | |
| Phone | 800-999-6423 | 
| pdicustomercare@pdihc.com | 
| Total Volume | 0.034 Fluid Ounce | 
| Total Volume | 0.034 Fluid Ounce | 
| Total Volume | 0.034 Fluid Ounce | 
| Total Volume | 0.034 Fluid Ounce | 
| Total Volume | 0.034 Fluid Ounce | 
| Total Volume | 0.034 Fluid Ounce | 
| Total Volume | 0.034 Fluid Ounce | 
| Total Volume | 0.034 Fluid Ounce | 
| Total Volume | 0.034 Fluid Ounce | 
| Total Volume | 0.034 Fluid Ounce | 
| Total Volume | 0.034 Fluid Ounce | 
| Total Volume | 0.034 Fluid Ounce | 
| Total Volume | 0.034 Fluid Ounce | 
| Total Volume | 0.034 Fluid Ounce | 
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00310819001526 [Primary] | 
| GS1 | 10310819001523 [Package] Contains: 00310819001526 Package: box [100 Units] In Commercial Distribution | 
| LKB | Pad, Alcohol, Device Disinfectant | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2020-08-11 | 
| Device Publish Date | 2020-08-03 | 
| 00310819000031 - Prevantics® Device Large Swab | 2024-02-23 Pre-moistened swab to disinfect needleless access sites prior to use. | 
| 00310819000482 - PDI® Lubricating Jelly II | 2020-10-19 Lubricating jelly to lubricate the body orifices to facilitate the entry of medical and therapeutic devices. | 
| 00310819000499 - PDI® Lubricating Jelly II | 2020-10-19 Lubricating jelly to lubricate the body orifices to facilitate the entry of medical and therapeutic devices. | 
| 10310819000304 - Hygea Sterile Saline Wipe | 2020-08-11 Wipe used for cleansing with a sterile saline solution where indicated | 
| 10310819000458 - PDI® Adhesive Tape Remover Pad | 2020-08-11 To remove adhesive tape from skin. | 
| 10310819000472 - PDI® Electrode Prep Pad | 2020-08-11 Pre-moistened pad used to remove surface skin oil and cleanse skin area in preparation for electrode placement. | 
| 10310819001523 - Prevantics® Device Swab | 2020-08-11Pre-moistened swab to disinfect needleless access sites prior to use. | 
| 10310819001523 - Prevantics® Device Swab | 2020-08-11 Pre-moistened swab to disinfect needleless access sites prior to use. | 
| 00310819001779 - Prevantics® Device Swab Strip | 2020-08-11 Pre-moistened swabs to disinfect needleless access sites prior to use. Strip of 8 swabs. | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  PREVANTICS  86181008  4709396 Live/Registered | Professional Disposables International,Inc. 2014-01-31 | 
|  PREVANTICS  85384684  4411529 Live/Registered | Professional Disposables International,Inc. 2011-07-29 |