WebTrade Name: Sterile Hypodermic Syringe with needle for Single Use Common Name: Syringe, Piston Regulatory Information Classification Name: Piston Syringe Classification: II; Product Code: FMF Regulation Number: 21CFR 880.5860 Review Panel: General Hospital Classification Name: Hypodermic single lumen needle Classification: II; Product Code: FMI WebMar 29, 2024 · Reviewed on 3/29/2024. Syringe: A medical device that is used to inject fluid into, or withdraw fluid from, the body. A medical syringe consists of a needle attached to …

510(K) Submissions for Piston Syringes Guidance

WebLow Dead Space Luer Lock Syringes Common Name: Piston Syringes Classification Name: Piston Syringe, 21 CFR §880.5860: Class II, Product code FMF . PREDICATE DEVICES: • K071459 B. Braun Omnifix® Piston Syringes . DEVICE DESCRIPTION . The Omnifix® Low Dead Space (LDS) Luer Lock Syringes consist of a ed graduat Sectors in the syringe and needle market include disposable and safety syringes, injection pens, needleless injectors, insulin pumps, and specialty needles. Hypodermic syringes are used with hypodermic needles to inject liquid or gases into body tissues, or to remove from the body. Injecting of air into a blood vessel is hazardous, as it may cause an air embolism; preventing embolisms by removing primary and excess insurance

Complete Guide: Medical Device Classification EU MDR …

Oral syringes are available in various sizes, from 1–10 mL and larger. An oral syringe is typically purple in colour to distinguish it from a standard injection syringe with a luer tip. The sizes most commonly used are 1 mL, 2.5 mL, 3 mL, 5 mL and 10 mL. Dental syringes See more A syringe is a simple reciprocating pump consisting of a plunger (though in modern syringes, it is actually a piston) that fits tightly within a cylindrical tube called a barrel. The plunger can be linearly pulled and pushed along … See more • Piston syringes were used in ancient times. During the 1st century AD Aulus Cornelius Celsus mentioned the use of them to treat … See more • Fire syringe has two meanings: • Autoinjector, a device to ease injection, e.g. by the patient or other untrained personnel. • Hippy Sippy • Jet injector, injects without a needle, by squirting the injection fluid so fast that it makes a hole in the skin. See more Sectors in the syringe and needle market include disposable and safety syringes, injection pens, needleless injectors, insulin pumps, and specialty needles. Hypodermic syringes are used with hypodermic needles to inject liquid or gases into body tissues, or to remove from the See more The syringe has many non-medical applications. Laboratory applications Medical-grade disposable hypodermic syringes are often used in research laboratories for convenience and low cost. Another application … See more • Hans-Jürgen Bässler und Frank Lehmann : Containment Technology: Progress in the Pharmaceutical and Food Processing Industry. Springer, … See more • Inventors of the hypodermic syringe • Hypodermic syringe patents • Medical syringe patents See more WebMar 20, 2024 · Aug 20, 2009. #5. Hi ropharm, If these pumps were used to infuse blood or other body liquids they would, in my opinion, be class IIa. If they are only recommended for use with drug or other non-body liquids they fall into class I, as ANNEX IV, section III, rule 2 for non-invasive devices in the MDD 93/42 EEC Regulations. WebDevice Classification Name: syringe, piston: 510(k) Number: K170386: Device Name: BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringe, BD Insulin Syringes with the BD Ultra-Fine™ needle and BD Insulin Syringes with Micro-Fine™ IV Needle: Applicant: Becton, Dickinson & Company: 1 Becton Drive: Franklin Lakes, NJ 07666 primary and contingent beneficiary