Identity
- Trade Name
- NIO FDA UDI
- Generic Name
- Intraosseous infusion kit FDA UDI
- Device Name
- The Pediatric NIO 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. FDA UDI
- Model / Reference
- NIO-P FDA UDI
- Description
- The Pediatric NIO 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290008325028 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
Similar devices
Also classified as Intraosseous infusion kit.
- Curaplex — BOUND TREE MEDICAL, LLC · Class II
- ARROW — TELEFLEX INCORPORATED · Class I
- RENOVA SPINE BONE FILLER — BIOPSYBELL SRL · Class IIa
- Spinertome kit — Adria S.r.l. · Class IIb
- Cook — COOK INCORPORATED · Class II
- RENOVA SPINE KYPHOPLASTY TOOL KIT — BIOPSYBELL SRL · Class IIa
- SPASY — Seawon Meditech Co.,Ltd. · Class IIa
- VERTEMAX KYPHOPLASTY TOOL KIT — BIOPSYBELL SRL · Class IIa
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- WaisMed Ltd
Sources (1)
- FDA UDI f969fabe-48c8-4cf8-a9fc-75850e7a17d2 35 fields · synced May 30, 2026