Ericka Neg. Pressure Arterial Blood Line
by Ericka
510(k) K812685
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK812685 | Date29 Sep 1981 | 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- Withdrawn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
- FJK
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5820
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Ericka Negative Pressure Arterial Blood Line is a Set, Tubing, Blood, With and Without Anti-Regurgitation Valve, designed for arterial blood collection and infusion. It facilitates controlled blood flow by utilizing negative pressure to draw arterial blood while preventing backflow through integrated anti-regurgitation valves. This device is intended for use in medical procedures requiring precise blood sampling or administration, particularly in gastroenterology and urology applications.
Supplied as a sterile, single-use device, the Negative Pressure Arterial Blood Line is regulated under FDA 510(k) clearance (K812685) and falls under Regulation 876.5820. It is intended for use in clinical settings where arterial blood access is required, such as during diagnostic procedures or therapeutic interventions. The device is packaged for one-time use and must be stored under conditions that maintain sterility until deployment. No MRI safety information is specified.
Questions
AI-generated answers, 1 Oct 2026
What is the Ericka Negative Pressure Arterial Blood Line used for?
The Ericka Negative Pressure Arterial Blood Line is designed for arterial blood collection and infusion in medical procedures requiring precise blood sampling or administration. It is particularly suited for gastroenterology and urology applications, where controlled blood flow is critical. The integrated anti-regurgitation valves prevent backflow, ensuring accurate sampling or infusion during diagnostic or therapeutic interventions.
Is the device single-use or reusable?
This device is supplied as a sterile, single-use product. It is intended for one-time use only to maintain sterility and prevent contamination, which is essential for safe and reliable arterial blood handling in clinical settings.
How should the Negative Pressure Arterial Blood Line be stored?
The device must be stored under conditions that preserve its sterility until deployment. This typically means keeping it in its original, unopened packaging in a clean, dry environment, away from direct sunlight or extreme temperatures, to ensure it remains uncontaminated and ready for use.
Does this device have any specific regulatory approvals?
The Ericka Negative Pressure Arterial Blood Line is regulated under FDA 510(k) clearance with the reference number K812685. It falls under Regulation 876.5820 and is classified as a Class II device, indicating it has undergone review by the FDA for safety and effectiveness.
Are there different models or sizes available for this blood line?
The device data includes multiple FEI numbers, which may correspond to variations in length, connector types, or valve configurations. However, specific details on exact sizes or models (e.g., tubing length, connector compatibility) are not provided in the description. For precise sizing or model selection, refer to the manufacturer’s technical documentation or contact Ericka directly.