NIO

GUDID 07290008325073

The NIO+ Adult is a single-use, automatic, spring-loaded, intraosseous sterile device with dual safety features for enhanced patient and caregiver safety. The NIO+ is packed in a rigid, low-profile case and can withstand extreme storage and usage conditions. After deployment, its built-in stabilizer base, in conjunction with a stand-alone NIO+ Fixation dressing, ensures that the needle is firmly secured

WaisMed Ltd

Intraosseous infusion kit

• Primary Device ID: 07290008325073
• NIH Device Record Key: ce5dba0c-23f7-49ff-826a-c52a25c55cf3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NIO
• Version Model Number: NIO Adult+
• Company DUNS: 514619238
• Company Name: WaisMed Ltd
• 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: true
• 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	07290008325073 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211968

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

Sterilization

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

[07290008325073]

Radiation Sterilization

[07290008325073]

Radiation Sterilization

[07290008325073]

Radiation Sterilization

[07290008325073]

Radiation Sterilization

[07290008325073]

Radiation Sterilization

[07290008325073]

Radiation Sterilization

[07290008325073]

Radiation Sterilization

[07290008325073]

Radiation Sterilization

[07290008325073]

Radiation Sterilization

[07290008325073]

Radiation Sterilization

[07290008325073]

Radiation Sterilization

[07290008325073]

Radiation Sterilization

[07290008325073]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-12
• Device Publish Date: 2025-08-04

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
• 07290008325073: The NIO+ Adult is a single-use, automatic, spring-loaded, intraosseous sterile device with dual