NIO Next Generation IO NIO-P

GUDID 10850026832003

Pediatric NIO Intraosseous

EINSTEIN WORKS, LLC

Intraosseous infusion kit

• Primary Device ID: 10850026832003
• NIH Device Record Key: 8cabde6c-4e77-48ab-81d2-ea862fa2d404
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NIO Next Generation IO
• Version Model Number: 1
• Catalog Number: NIO-P
• Company DUNS: 098121274
• Company Name: EINSTEIN WORKS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850026832006 [Primary]
GS1	10850026832003 [Package]; Contains: 00850026832006; Package: Box [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191258

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-17
• Device Publish Date: 2021-02-09

On-Brand Devices [NIO Next Generation IO]

• 10850026832034: ADULT NIO INTRAOSSEOUS
• 10850026832003: Pediatric NIO Intraosseous
• 10850026832027: INFANT NIO INTRAOSSEOUS
• 10850026832102: NIO FIXATION DRESSING