Device |
low dead space piston syringe |
Regulation Description |
Piston syringe. |
Definition |
A low dead space syringe is a piston syringe designed to reduce medication waste. The device consists of a calibrated hollow barrel, a moveable plunger, and may include a needle. The device can be used by health care professions or for self-injection by the patient. |
Physical State |
A low dead space syringe consists of a syringe barrel, a plunger, and may include a needle. The plunger and barrel are typically made of a polymeric material whereas the needle is made from stainless steel. The syringe plunger, syringe nozzle and/or needle of the syringe is designed to reduce medication waste. |
Technical Method |
Low dead space syringes are operated manually by pushing or pulling the plunger to expel or withdraw a liquid. |
Target Area |
Target injection sites may include subcutaneous, intramuscular, intravascular, intradermal and intravitreal. |
Regulation Medical Specialty |
General Hospital |
Review Panel |
General Hospital |
Product Code | QNQ |
Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Drug Delivery and General Hospital Devices, and Human Factors
(DHT3C)
|
Submission Type |
510(k)
|
Regulation Number |
880.5860
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |
|
|