NIO

GUDID 17290008325025

The Pediatric NIO device is indicated to provide intraosseous access in the proximal tibia as an alternative to IV access during emergencies. The devi

WaisMed Ltd

Intraosseous infusion kit Intraosseous infusion kit Intraosseous infusion kit Intraosseous infusion kit Intraosseous infusion kit Intraosseous infusion kit Intraosseous infusion kit Intraosseous infusion kit Intraosseous infusion kit Intraosseous infusion kit Intraosseous infusion kit Intraosseous infusion kit Intraosseous infusion kit Intraosseous infusion kit Intraosseous infusion kit

• Primary Device ID: 17290008325025
• NIH Device Record Key: f969fabe-48c8-4cf8-a9fc-75850e7a17d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NIO
• Version Model Number: NIO-P
• Company DUNS: 514619238
• Company Name: WaisMed Ltd
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-888-737-7978
• Email: info@ps-med.com
• Phone: 1-888-737-7978
• Email: info@ps-med.com
• Phone: 1-888-737-7978
• Email: info@ps-med.com
• Phone: 1-888-737-7978
• Email: info@ps-med.com
• Phone: 1-888-737-7978
• Email: info@ps-med.com
• Phone: 1-888-737-7978
• Email: info@ps-med.com
• Phone: 1-888-737-7978
• Email: info@ps-med.com
• Phone: 1-888-737-7978
• Email: info@ps-med.com
• Phone: 1-888-737-7978
• Email: info@ps-med.com
• Phone: 1-888-737-7978
• Email: info@ps-med.com
• Phone: 1-888-737-7978
• Email: info@ps-med.com
• Phone: 1-888-737-7978
• Email: info@ps-med.com
• Phone: 1-888-737-7978
• Email: info@ps-med.com
• Phone: 1-888-737-7978
• Email: info@ps-med.com
• Phone: 1-888-737-7978
• Email: info@ps-med.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290008325028 [Primary]
GS1	17290008325025 [Package]; Contains: 07290008325028; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160805

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-12

On-Brand Devices [NIO]

• 17290008325056: The NIO-A device is indicated to provide intraosseous access into the proximal tibia and proxima
• 17290008325025: The Pediatric NIO device is indicated to provide intraosseous access in the proximal tibia as an
• 07290008325066: The NIO-Infant (NIO-I) is an intraosseous device intended to provide vascular access in the prox
• 07290008325080: The NIO Pediatric device is indicated to provide intraosseous access in the proximal tibia as an