Prevantics® Device Swab Strip B123ST

GUDID 00310819001779

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

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

• Primary Device ID: 00310819001779
• NIH Device Record Key: dd417768-f15d-44b1-9acc-a2eda28f394a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prevantics® Device Swab Strip
• Version Model Number: B123ST
• Catalog Number: B123ST
• 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
• Email: pdicustomercare@pdihc.com
• Phone: 800-999-6423
• Email: pdicustomercare@pdihc.com
• Phone: 800-999-6423
• Email: pdicustomercare@pdihc.com
• Phone: 800-999-6423
• Email: pdicustomercare@pdihc.com
• Phone: 800-999-6423
• Email: pdicustomercare@pdihc.com
• Phone: 800-999-6423
• Email: pdicustomercare@pdihc.com
• Phone: 800-999-6423
• Email: pdicustomercare@pdihc.com
• Phone: 800-999-6423
• Email: pdicustomercare@pdihc.com
• Phone: 800-999-6423
• Email: pdicustomercare@pdihc.com
• Phone: 800-999-6423
• Email: pdicustomercare@pdihc.com
• Phone: 800-999-6423
• Email: pdicustomercare@pdihc.com
• Phone: 800-999-6423
• Email: pdicustomercare@pdihc.com
• Phone: 800-999-6423
• Email: pdicustomercare@pdihc.com
• Phone: 800-999-6423
• Email: pdicustomercare@pdihc.com

Device Dimensions

• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00310819001779 [Primary]
GS1	10310819001776 [Package]; Package: box [160 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: 2020-08-11
• Device Publish Date: 2020-08-03

Devices Manufactured by PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.

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• 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: 2020-08-11Pre-moistened swabs to disinfect needleless access sites prior to use. Strip of 8 swabs.
• 00310819001779 - Prevantics® Device Swab Strip: 2020-08-11 Pre-moistened swabs to disinfect needleless access sites prior to use. Strip of 8 swabs.