← Back to catalogue

One-Day/Five-Day/Seven-Day Syringe Mate

FDA 510(k)

Class II (US FDA 510(k))

510(k) K971168

by Baxter Healthcare Corp

Identifiers

510(k) Number
K971168 FDA 510(k)
FDA Product Code
MEB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5725 FDA 510(k)
Regulation Number
880.5725 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The One-Day/Five-Day/Seven-Day Syringe Mate is an elastomeric infusion pump designed for the delivery of medications. It is categorized as a Class II medical device and is intended for use in general hospital settings.

The device is supplied in various configurations for one-day, five-day, and seven-day use. It is manufactured by Baxter Healthcare Corp and has FDA 510(k) clearance with the product code MEB. The device is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ONE-DAY/FIVE-DAY/SEVEN-DAY SYRINGE MATE (K971168) — FDA 510 (k ..., ONE-DAY/FIVE-DAY/SEVEN-DAY SYRINGE MATE (K971168) — FDA 510 (k ..., FDA 510 (k) Applications Submitted by BAXTER HEALTHCARE CORP., PDF www.accessdata.fda.gov

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Baxter Healthcare Corp

Sources (1)

  • FDA 510(k) K971168 24 fields · synced Oct 6, 2026