Identity
- Trade Name
- NIO FDA UDI
- Generic Name
- Intraosseous infusion kit FDA UDI
- Device Name
- The NIO Pediatric device is indicated to provide intraosseous access in the proximal tibia as an alternative to IV access during emergencies. The device is for use in pediatric patients up to 12 years of age. New stabilizer for the pediatric device FDA UDI
- Model / Reference
- NIO-P FDA UDI
- Description
- The NIO Pediatric device is indicated to provide intraosseous access in the proximal tibia as an alternative to IV access during emergencies. The device is for use in pediatric patients up to 12 years of age. New stabilizer for the pediatric device FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290008325080 FDA UDI
- 510(k) Number
- K160805 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
No
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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Cleared under the same submission
K160805 also covers:
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 a116d3f0-b097-4dfc-9afd-61eb46e3eb2b 35 fields · synced May 31, 2026