Identity
- Trade Name
- NIO FDA UDI
- Generic Name
- Intraosseous infusion kit FDA UDI
- Device Name
- The NIO-Infant (NIO-I) is an intraosseous device intended to provide vascular access in the proximal tibia of infants as an alternative to emergency IV access. It is indicated for use in infants between gestational age of 36 weeks and weight of at least 5 pounds (2.3 Kg) and up to 3 years of age. FDA UDI
- Model / Reference
- NIO-I FDA UDI
- Description
- The NIO-Infant (NIO-I) is an intraosseous device intended to provide vascular access in the proximal tibia of infants as an alternative to emergency IV access. It is indicated for use in infants between gestational age of 36 weeks and weight of at least 5 pounds (2.3 Kg) and up to 3 years of age. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290008325066 FDA UDI
- 510(k) Number
- K190538 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
A comprehensive intraosseous infusion device designed for infants, suitable as an emergency IV access alternative in cases of cardiac arrest, respiratory failure or shock.
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
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 478a1c39-98fb-4570-b555-546aa039a695 34 fields · synced Jul 21, 2026