Tygon PAC-Monitoring Lines & Fluid Admin
by Norton Performance Plastics Corp. 2 variants
510(k) K770707
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK770707 | Date3 Jun 1977 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FMG
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5440
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Tygon PAC-Monitoring Lines & Fluid Admin are intravenous (I.V.) administration sets and stopcocks designed for fluid administration and monitoring in clinical settings. These devices facilitate the controlled delivery of fluids, medications, or nutrients to patients while enabling real-time monitoring of infusion parameters. They are categorized as Class II medical devices, incorporating tubing and connectors for secure and sterile fluid pathways.
These lines are intended for single-use in hospital environments, adhering to sterile processing standards. They are compatible with standard medical equipment and are regulated under FDA 510(k) clearance (K770707) as substantially equivalent to predicate devices. The product code FMG and regulation number 880.5440 further classify them under the Stopcock and I.V. Set category. Multiple reference codes (e.g., 3009211636, 1000112877) denote specific variants, ensuring compatibility with diverse medical systems.
Other devices from Norton Performance Plastics Corp.
Questions
AI-generated answers, 1 Oct 2026
What are the Tygon PAC-Monitoring Lines & Fluid Admin designed for?
These devices are designed for intravenous (I.V.) fluid administration and monitoring in clinical settings. They facilitate the controlled delivery of fluids, medications, or nutrients to patients while enabling real-time monitoring of infusion parameters. The tubing and connectors ensure secure and sterile fluid pathways, making them ideal for hospital environments where precise fluid management is critical.
Are the Tygon PAC-Monitoring Lines & Fluid Admin single-use or reusable?
The Tygon PAC-Monitoring Lines & Fluid Admin are explicitly designed for single-use only. This aligns with sterile processing standards in clinical settings to prevent contamination and ensure patient safety. Reuse is not recommended or supported by the manufacturer.
What reference codes or models are available for the Tygon PAC-Monitoring Lines & Fluid Admin?
The Tygon PAC-Monitoring Lines & Fluid Admin come in multiple reference codes to ensure compatibility with diverse medical systems. Some of the reference codes include 3009211636, 1000112877, 3003737899, and many others listed under the OpenFDA registration. These variants allow healthcare providers to select the appropriate model for their specific equipment and workflow requirements.
How should the Tygon PAC-Monitoring Lines & Fluid Admin be stored?
While the provided data does not specify storage conditions explicitly, single-use medical devices like these typically require storage in a clean, dry environment protected from direct sunlight, extreme temperatures, and physical damage. It is also important to follow the manufacturer’s guidelines or any accompanying documentation for optimal storage practices to maintain sterility and functionality until use.
Are these devices compatible with standard medical equipment?
Yes, the Tygon PAC-Monitoring Lines & Fluid Admin are designed to be compatible with standard medical equipment commonly used in hospital settings. The availability of multiple reference codes further ensures that these devices can integrate seamlessly with various infusion systems and monitoring tools, reducing the risk of compatibility issues during clinical use.