Description
FDA 510(k) Cleared Medical Device for Precision Drug Delivery
Product Overview
The NEST Professional Reusable Pen Injector is an FDA-cleared medical device designed for precise, convenient self-administration of injectable medications. This durable pen system provides accurate dosing for patients requiring regular injections.
Key Features
FDA Cleared & Certified
- FDA 510(k): K240774
- ISO 13485 certified manufacturing
- CE MDR compliant
- Meets YY/T 1768.1-2021 international standards
Precision Dosing
- Up to 60 units in 0.01mL increments
- ±5% accuracy validated across multiple conditions
- Clear dose window with easy-to-read markings
- Audible click confirmation for each unit
Universal Compatibility
- Standard 3mL cartridge system
- Compatible with universal pen needles (sold separately)
- Suitable for various injectable medications as prescribed
User-Friendly Design
- Ergonomic grip for comfortable handling
- Lightweight, balanced construction
- Simple cartridge replacement
- Available colors: Blue, Black, and custom options
Quality & Safety
- Injection force < 30N
- Drop-tested and vibration-tested
- 5-year shelf life
- Cleanroom manufactured (ISO Class 7/8)
Technical Specifications
- Dose Range: 0-60 units (0.6mL max)
- Minimum Increment: 0.01mL
- Cartridge Size: 3mL standard
- Storage: 10-30°C, <80% RH
- Materials: Medical-grade polymers (ROHS/REACH compliant)
Package Contents
- 1 Reusable Pen Injector
- User manual
- Needles and medication cartridges sold separately
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