FDA-Cleared 510(k) Reusable 80 Unit Injection Pen
FDA-Cleared 510(k) Reusable 80 Unit Injection Pen
★★★★★(6 customer reviews)FDA-Cleared 510(k) Reusable 80 Unit Injection Pen
FDA-cleared precision dosing device for injectable medications. Delivers 0-80 units in 0.01mL increments with audible click confirmation. Ergonomic design, universal 3mL cartridge compatibility.
FDA 510(k) Cleared Medical Device for Precision Delivery
Product Overview
The Reusable 80 Unit Injection Pen 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.
Manufactured by Nest Scientific USA.
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 80 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
Quality & Safety
- Low pressing force: <5N at 36–37 units, <8N at 74–80 units
- Drop-tested and vibration-tested
- Reusable pen rated for 3,000 injection cycles
- 5-year shelf life
- Cleanroom manufactured (ISO Class 7/8)
Technical Specifications
- Dose Range: 0-80 units (0.8mL 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
- 1 Durable carrying case
- User manual
- Needles and medication cartridges sold separately
Customer Reviews (6)
Much better than generic injectors. Easy to fill, easy to use - great!
Pretty great, overall. Unclear on how the volume dispensing works, it just 1, 2, 3, etc., but not sure what that represents. CC?
Have not tried the pen yet. But I will comment on the packaging and the drop off. Fast and easy. Superb service from them and fast communication as well. I will buy more for sure.
works perfectly
Very quick delivery and works great!