Definition: The Connector For Neuraxial Applications Is Intended To Facilitate ANSI/AAMI/ISO 80369-6:2016 Compliant Neuraxial Specific Connections.
| Device Type ID | 2761 |
| Device Name | Administrations Sets With Neuraxial Connectors |
| 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 |
| Target Area | The Neuraxial Space |
| Regulation Description | Intravascular Administration Set. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 880.5440 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PWH |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
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| Device Type ID | 2761 |
| Device | Administrations Sets With Neuraxial Connectors |
| Product Code | PWH |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Intravascular Administration Set. |
| CFR Regulation Number | 880.5440 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
SMITHS | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SMITHS GROUP PLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |