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 |