| Device |
administrations sets with neuraxial connectors |
| Regulation Description |
Intravascular administration set. |
| Definition |
The connector for neuraxial applications is intended to facilitate ANSI/AAMI/ISO 80369-6:2016 compliant neuraxial specific connections. |
| Physical State |
The connector consists of a ISO 80369-6 compliant connection and may be composed of plastic. |
| Technical Method |
The neuraxial connector is attached to a small bore connector intended to be used for neuraxial applications and intended to facilitate in administration of medication or act as a transitional piece to be used with administration sets with a non ISO 80369-6 compliant connection. |
| Target Area |
The neuraxial space |
| Regulation Medical Specialty |
General Hospital |
| Review Panel |
General Hospital |
|---|
| Product Code | PWH |
|---|
| 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 |
880.5440
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Recognized Consensus Standards
|
| Third Party Review |
Not Third Party Eligible |
