Prevantics® Device Large Swab C71200
GUDID 00310819000031
Pre-moistened swab to disinfect needleless access sites prior to use.
PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.
Medical device cleaning/disinfection wipe Medical device cleaning/disinfection wipe Medical device cleaning/disinfection wipe Medical device cleaning/disinfection wipe Medical device cleaning/disinfection wipe Medical device cleaning/disinfection wipe Medical device cleaning/disinfection wipe Medical device cleaning/disinfection wipe Medical device cleaning/disinfection wipe Medical device cleaning/disinfection wipe Medical device cleaning/disinfection wipe Medical device cleaning/disinfection wipe Medical device cleaning/disinfection wipe Medical device cleaning/disinfection wipe Medical device cleaning/disinfection wipe Medical device cleaning/disinfection wipe Medical device cleaning/disinfection wipe Medical device cleaning/disinfection wipe| Primary Device ID | 00310819000031 |
| NIH Device Record Key | 43860018-0782-419b-964d-835e9dfd26f1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Prevantics® Device Large Swab |
| Version Model Number | C71200 |
| Catalog Number | C71200 |
| 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 |
Customer Support Contacts
| 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 | |
| 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 |
Device Dimensions
| Total Volume | 0.04 Fluid Ounce |
| Total Volume | 0.04 Fluid Ounce |
| Total Volume | 0.04 Fluid Ounce |
| Total Volume | 0.04 Fluid Ounce |
| Total Volume | 0.04 Fluid Ounce |
| Total Volume | 0.04 Fluid Ounce |
| Total Volume | 0.04 Fluid Ounce |
| Total Volume | 0.04 Fluid Ounce |
| Total Volume | 0.04 Fluid Ounce |
| Total Volume | 0.04 Fluid Ounce |
| Total Volume | 0.04 Fluid Ounce |
| Total Volume | 0.04 Fluid Ounce |
| Total Volume | 0.04 Fluid Ounce |
| Total Volume | 0.04 Fluid Ounce |
| Total Volume | 0.04 Fluid Ounce |
| Total Volume | 0.04 Fluid Ounce |
| Total Volume | 0.04 Fluid Ounce |
| Total Volume | 0.04 Fluid Ounce |
Operating and Storage Conditions
| 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 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00310819000031 [Primary] |
| GS1 | 10310819000038 [Package] Package: box [150 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K132380
FDA Product Code
| LKB | Pad, Alcohol, Device Disinfectant |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-02-23 |
| Device Publish Date | 2024-02-15 |
Devices Manufactured by PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.
| 00310819000031 - Prevantics® Device Large Swab | 2024-02-23Pre-moistened swab to disinfect needleless access sites prior to use. |
| 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 | 2020-08-11 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. |
Trademark Results [Prevantics]
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 |
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