NIO Intraosseous Device w/Fixation Dressing - Ruggerized - Safeguard Medical

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NIO Intraosseous Device w/Fixation Dressing - Ruggerized

Name: NIO Intraosseous Device w/Fixation Dressing - Ruggerized
Brand: Safeguard Medical
SKU: NIO+
Price: 301.0 CAD
Availability: InStock

Your Price: $301.00

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SKU: NIO+

Type: IV/IO Device

Vendor: Safeguard Medical

PRODUCT INFORMATION

The NIO+ Ruggerized Intraosseous Device (SKU NIO+) is the military/tactical-grade version of the NIO Adult IO access device — offering the same spring-loaded automatic IO access in 10 seconds or less with no batteries, no assembly, and no extra parts, packaged in an enhanced ruggerized casing designed to withstand the mechanical stresses of tactical loadout, extreme environments, and field handling. FDA-cleared for proximal tibia and proximal humerus access in adult patients.

Key Specifications

Specification	Detail
Manufacturer	PerSys Medical / Safeguard Medical
SKU	NIO+
Weight (packaged)	6.0 oz
Needle Gauge	15G
Needle Effective Length	42 mm (1.65 in.)
Needle Penetration Depth	25 mm (0.98 in.)
Mechanism	Automatic spring-loaded
Indication	Adult proximal tibia and proximal humerus IO access
Packaging	Individual peel-back blister pack with fixation dressing — ruggerized casing
Sterility	Sterile, single-use
Shelf Life	5 years from manufacture
FDA 510(k)	K211968
Safety Mechanisms	Rotating safety latch + simultaneous dual-activation required

Product Overview

When peripheral IV access fails in a critically ill adult — hypovolemic trauma, cardiac arrest, septic shock, burns — intraosseous access provides a non-collapsible vascular route that achieves drug and fluid delivery equivalent to IV administration. The NIO+ Ruggerized is the tactical-grade specification of the NIO Adult, engineered for the demands of military medical kits, austere field environments, and high-frequency operational use where standard devices may be subjected to mechanical stress, temperature extremes, and rough handling that compromises device integrity.

The NIO+ ruggerized casing addresses a specific operational concern: IO devices are precision spring-loaded instruments. Drop damage, compression in a packed kit, temperature cycling from arctic to desert conditions, or high-G CASEVAC vibration can affect spring preload and device function. The ruggerized packaging provides enhanced mechanical protection while maintaining the same sterile blister-pack presentation as the standard NIO Adult — the clinical performance is identical, with the ruggerized platform providing confidence in device integrity after field handling.

Clinically, the NIO+ delivers 15-gauge access in adult proximal tibia and proximal humerus locations. The 15G lumen diameter supports high-flow fluid administration, blood product delivery (whole blood, packed RBCs, FFP), and all emergency medications at IV-equivalent pharmacokinetics. Vascular access is achieved in 10 seconds or less with no external power source — the self-contained spring mechanism fires with a single-motion dual-activation sequence (downward pressure + trigger wing compression).

The proximal humerus site (humeral head) is increasingly recognized as a preferred adult IO site for rapid fluid resuscitation, offering larger marrow cavity volume and potentially higher flow rates than the proximal tibia — particularly useful for damage control resuscitation requiring rapid volume loading. The NIO+ is cleared for both tibia and humerus sites.

Tibia vs. Humerus IO Site: Considerations

Specification	Detail
Proximal Tibia	Primary default site; easily accessible in supine patient; easily landmarked; 15g NIO+ cleared
Proximal Humerus	Higher flow rates possible; preferred for rapid resuscitation; patient position should allow shoulder access; requires abduction if possible
Site Selection Guidance	Use tibia for initial access; consider humerus if higher flow resuscitation rates are needed or tibial access fails

IO vs. IV Access: Clinical Decision Context

Per TCCC and ACLS guidelines, IO access is indicated when IV access cannot be established in a timely fashion in a time-critical emergency. The 'two-attempt rule' in cardiac arrest (attempt IV twice, then IO) reflects the clinical consensus that IO access is sufficiently fast and reliable to substitute for IV in emergencies. For tactical medics operating in Care Under Fire and Tactical Field Care phases, IO access via the NIO+ provides a rapid, reliable fallback when peripheral venous access is compromised by hypovolemia, environmental conditions, or patient anatomy.

FREQUENTLY ASKED QUESTIONS

What makes the NIO+ different from the standard NIO Adult?

The NIO+ Ruggerized uses the same spring-loaded automatic mechanism, 15G needle, 25 mm penetration depth, and clinical performance as the standard NIO Adult. The differentiation is in the outer packaging and device casing, which is ruggerized to withstand the mechanical stresses of tactical kit packing, drop damage, temperature extremes, and field handling that could compromise a standard precision spring device. For military and tactical users who need confidence in device integrity after extended field deployment, the NIO+ is the appropriate specification.

How fast does the NIO+ achieve IO access?

The NIO+ achieves IO access in 10 seconds or less under normal conditions. The spring-loaded automatic mechanism fires after the two-step activation sequence (rotating safety latch 90° + simultaneous downward pressure and trigger wing compression), delivering controlled, consistent needle penetration through the cortex in a single motion. Clinical data supports a 98% first-attempt success rate for NIO devices.

What sites is the NIO+ cleared for in adults?

The NIO+ is FDA-cleared (510(k) K211968) for intraosseous access in the proximal tibia and proximal humerus (humeral head) of adult patients in emergent situations. The proximal tibia is the standard primary site due to ease of positioning and landmarking. The proximal humerus is increasingly used for rapid fluid resuscitation due to its larger marrow cavity and potentially higher achievable flow rates.

Can the NIO+ be used with the Go IO Start Kit?

Yes. The Go IO Intraosseous Start Kit is designed for use with the NIO Adult and NIO+ devices. It provides the 90° IV extension set connector, three-way stopcock, NIO fixation securement dressing, NeedleVISE sharps safety block, and secure IV strap — all components needed to convert NIO+ IO access into a functional, secured IV line for fluid resuscitation and drug delivery.

Note: Is there a current recall on any NIO+ lots?

Yes — as of June 2025, WaisMed / Safeguard Medical issued an urgent recall notice (FDA Recall Z-2119-2025) for certain lots of NIO A and NIO+ devices due to a quality concern. Healthcare providers should verify current lot recall status through the FDA and Safeguard Medical before deploying NIO+ devices and follow manufacturer guidance for affected lot disposal. MED-TAC International ships NIO+ devices from verified, non-recalled stock — contact us to confirm lot status on any NIO+ order.