Pen Injector (K240774)
by Wuxi Nest Biotechnology Co., Ltd. EUDAMED510(k)
Active
510(k) K240774
Overview
The Pen Injector is a medical device classified as a drug delivery system designed for the subcutaneous administration of medications. It is engineered to provide precise dosing of liquids, including insulin or other injectable therapies, with minimal user intervention, enhancing convenience and accuracy for patients.
This device is intended for single-use in hospital or clinical settings and is sterile upon packaging. It is not MRI-safe and must be stored under controlled conditions as specified by the manufacturer. Authorised under FDA 510(k) clearance and MDR, it adheres to regulatory standards for drug delivery systems in general hospital environments.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK240774 | Date18 Jun 2024 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- Full name
- Pen Injector
- 510(k) Number
- FDA Product Code
- FMF
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5860
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Other devices from Wuxi Nest Biotechnology Co., Ltd.
Questions
What types of medications can this Pen Injector be used for, and why is it designed for single-use in clinical settings?
The Pen Injector is specifically designed for the subcutaneous administration of liquid medications like insulin or other injectable therapies. It enhances convenience and accuracy by reducing user intervention. It is intended for single-use only in hospital or clinical settings to ensure sterility and safety, as it comes sterile upon packaging and is not intended for reuse.
How should I store this Pen Injector, and what precautions should I take during storage?
The Pen Injector must be stored under controlled conditions as specified by the manufacturer. Since it is sterile upon packaging and intended for single-use, proper storage ensures its integrity and functionality. Avoid exposure to extreme temperatures or contamination, and follow the manufacturer’s guidelines to maintain its performance.
Is this device compatible with MRI procedures, and if not, why is that important?
No, this Pen Injector is not MRI-safe. This is important because MRI machines use strong magnetic fields, and non-MRI-safe devices could be damaged or pose risks during the procedure. Always confirm compatibility with imaging equipment before use.
What regulatory pathways does this Pen Injector follow, and how does that affect its use in hospitals?
This Pen Injector is authorized under FDA 510(k) clearance and MDR (Medical Device Regulation) standards. These pathways ensure it meets safety and performance requirements for drug delivery systems in general hospital environments. Hospitals can rely on these approvals to confirm its suitability for clinical use.