Identity
- Trade Name
- NIO FDA UDI
- Generic Name
- Intraosseous infusion kit FDA UDI
- Device Name
- 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 FDA UDI
- Model / Reference
- NIO Adult+ FDA UDI
- Description
- 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 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290008325073 FDA UDI
- 510(k) Number
- K211968 FDA UDI
- FDA Product Code
- FMI FDA UDI
- GMDN Term
- Intraosseous infusion kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Radiation Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Intraosseous infusion kit
Nio by WaisMed Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- WaisMed Ltd
Sources (1)
- FDA UDI ce5dba0c-23f7-49ff-826a-c52a25c55cf3 34 fields · synced May 30, 2026