ASN Monitor Single Needle Monitor

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K843531 ↗

FDA Product Code

KOC

Device Class

Class II

Regulation

21 CFR Part 876.5820

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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• What is the ASN Single Needle Monitor used for?

  The ASN Single Needle Monitor is designed for continuous or intermittent arterial blood sampling to measure critical parameters such as pH, partial pressure of oxygen (PaO₂), and partial pressure of carbon dioxide (PaCO₂). It is specifically intended as an accessory for blood circuit applications in hemodialysis systems and is used in clinical settings where precise monitoring of arterial blood gases is required, such as in gastroenterology and urology procedures.

• Is the ASN Single Needle Monitor sterile?

  No, the ASN Single Needle Monitor is supplied as a non-sterile device. It is intended for single-use only, meaning it should not be reused after one procedure to maintain safety and accuracy. Always follow manufacturer guidelines for handling and disposal.

• What specialties is this device approved for?

  The ASN Single Needle Monitor is regulated under FDA 510(k) clearance (K843531) and is approved for use in gastroenterology and urology specialties. It adheres to regulatory standards outlined in 21 CFR 876.5820, ensuring compliance for procedures requiring arterial blood monitoring in these fields.

• How is the ASN Single Needle Monitor supplied?

  The device is supplied as a single-use instrument, meaning each unit is intended for one procedure only. It is non-sterile, so proper handling and disposal protocols must be followed to prevent contamination. Always check the packaging for expiration dates and storage instructions before use.

• What parameters does the ASN Single Needle Monitor measure?

  The ASN Single Needle Monitor is designed to measure key arterial blood gas parameters, including pH, partial pressure of oxygen (PaO₂), and partial pressure of carbon dioxide (PaCO₂). These measurements are essential for assessing respiratory and metabolic status in clinical settings, particularly during hemodialysis or other procedures requiring precise blood monitoring.