| Device |
low dead space needle, single lumen, hypodermic |
| Regulation Description |
Hypodermic single lumen needle. |
| Definition |
A low dead space single lumen hypodermic needle is a device designed to reduce medication waste. The device consists of a metal tube that is sharpened at one end and at the other end joined to connector designed to mate with a piston syringe. It may or may not have needle safety features. The device can be used by health care professions or for self-injection by the patient. |
| Physical State |
A low dead space needle consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub). The needle hub or connector of the needle is designed to reduce medication waste. |
| Technical Method |
Low dead space needles are operated manually by attaching it to a piston syringe. |
| Target Area |
Target injection sites may include subcutaneous, intramuscular, intravascular, intradermal, ophthalmic. |
| Regulation Medical Specialty |
General Hospital |
| Review Panel |
General Hospital |
|---|
| Product Code | QNS |
|---|
| 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 |
880.5570
|
|---|
| 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 |
