| 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 |
Drug Delivery and General Hospital Devices, and Human Factors
(DHT3C)
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 |
