LT-1115 NH

Manufacturer Part Number

Lock-Tight

Bite Block

Peace of mind for respiratory therapists everywhere. Secure, standardized bite protection that integrates seamlessly with modern airway management workflows.

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Nadia-health inc

Hospital-Ready Airway Management Compliance Overview

Lock-Tightâ„¢ Bite Block

Designed to help protect endotracheal tubes and support airway management in ventilated patients across ICU, OR, emergency, and critical care settings.

FDA Registered #: 3043473562

NADIA-HEALTH INC

Class 1 Device

Medical Device Classification

510(k) Exempt

No premarket 510(k) required

Product Code: MNK

FDA device category

Owner / Operator #: 10095276

FDA FURLS / DRLM record

Hospital Evaluation Ready

Structured review support available

FDA Registered

NADIA-HEALTH INC

Class Device

Medical Device Classification

510(k) Exempt

No premarket 510(k) required

Product Code: MNK

FDA device category

Owner / Operator #: 10095276

FDA FURLS / DRLM record

Hospital Evaluation Ready

Structured review support available

Regulatory & Clinical Compliance

NADIA-HEALTH INC is registered through the FDA Unified Registration and Listing System (FURLS/DRLM). The Lock-Tightâ„¢ Bite Block is regulated as a Class | medical device, product code MNK, and is 510(k) exempt under U.S. FDA medical device regulations.

Company: NADIA-HEALTH INC

Address: 600 Park Offices Drive, Suite 300, Durham, North Carolina 27713, USA

FDA Owner / Operator Number: 10095276

Product: Lock-Tight™ Bite Block

Regulatory Status: Class | Medical Device | 510(k) Exempt | Product Code MNK

Hospital Review Readiness

Documentation can be provided to hospital supply chain, respiratory therapy, and value analysis teams upon request, including FDA registration confirmation, device listing information, product overview materials, and clinical evaluation support details.

NADIA-HEALTH supports structured product evaluations for hospitals assessing airway management accessories within respiratory therapy and critical care workflows.

LT-1115 NH

Manufacturer Part Number

Lock-Tight

Bite Block

Lock-Tight

Bite Block

Lock-Tight

Bite Block

LT-1115 NH

Manufacturer Part Number

Peace of mind for respiratory therapists everywhere. Secure, standardized bite protection that integrates seamlessly with modern airway management workflows.
Product Lead Form

Designed for Real-World Healthcare

Lock-Tight offers a standardized, user-friendly care approach that integrates with modern airway management workflows. by reducing preventable oral injuries, this initiative enhances patient safety, improves clinical outcomes, and raises professional standards at the bedside.

  • Secure Protection
  • Stable Positioning
  • Complete Compatibility
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Lock-Tightâ„¢ Respiratory-Led
Pilot Program

Lock-Tightâ„¢ Respiratory-Led Pilot Program

Hospital Evaluation Packet This packet outlines the components of the Lock-Tight™ Respiratory Therapy–led pilot program, designed to support clinical evaluation, patient safety, standardization, and Value Analysis review

01.

Pilot supply of Lock-Tightâ„¢ Bite-Block

is provided to support a 60–90 day evaluation period. The device is single-use, non-capital, and requires no inventory commitment.

02.

Executive VAC Summary

A one-page Executive Value Analysis Committee (VAC) summary is included to support evaluation approval and internal governance review.

03.

Respiratory-Led Pilot Protocol

The pilot protocol defines scope, duration, oversight, and evaluation criteria, and is owned by Respiratory Therapy leadership.

04.

Policy & Procedure Alignment

Hospital-ready policy and procedure templates are provided to support clinical standardization without modifying existing airway management protocols.

05.

Education & Bedside Tools

Brief education materials and a bedside quick-reference checklist support consistent and safe use with minimal training burden.

06.

Pilot Feedback & Outcomes

Standardized tools are included to capture quantitative and qualitative Respiratory Therapy feedback and support objective leadership review.

07.

Post-Pilot Executive Summary

A one-page executive summary template supports clear documentation of pilot findings and clinical recommendations.
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Early Detection

  • Improves patient safety and comfort
  • Reduces oral injury and dental risk.
  • Eliminates inconsistent improvised practices.
  • Reduces endotracheal tube occlusion or damage.

Proposed Solution

  • Secure bite protection without excessive pressure.
  • Stable positioning during ventilation
  • Simple placement with minimal training
  • Compatibility with existing airway workflows

Operational Impact

  • faster and more consistent placement
  • Less frequent repositioning
  • RT-led in-service (<10 minutes)
  • No new competencies or certifications required

Standardization & Compliance

  • Supports system-wide airway standardization
  • Reduces variablility across departments and sihifts
  • Aligns with patient safety and quality initiatives

Innovative

Cutting-edge design backed by respiratory care expertise and clinical insights.

Safety First

Engineered with patient safety as the primary consideration in every detail.

Care Inspired

Engineered with patient safety as the primary consideration in every detail.

Quality Assured

Cutting-edge design backed by respiratory care expertise and clinical insights.
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Nadia-Health Inc

  • HealthTrust Performance Group - 962998
  • Supplier Gateway - Approved
  • SupplierONE - Approved

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