Definition: Spacers Are Devices That Are Used With Nebulizers And Metered Dose Inhalers That Are Comprised Of A Reservior Into Which An Aerosol Medication Is Dispensed. A Spacer Uses An Open Mouthpiece. Spacers Are Intended To Minimize Delivery Of Large Aerosoli
| Device Type ID | 169 |
| Device Name | Spacer, Direct Patient Interface |
| Physical State | Spacers Are Frequently Made Of Plastic, And Can Be Tube Shapped. |
| Technical Method | By Holding Drugs After Aerosolization, Spacers Are Intended To Minimize Delivery Of Large Aerosolized Particles, Which Would Otherwise Deposit In The Mouth. |
| Target Area | Spacers Contact The Mouth. The Drug They Are Holding Is Intended For The Lower Airways |
| Regulation Description | Nebulizer. |
| Regulation Medical Specialty | Anesthesiology |
| Review Panel | Anesthesiology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Respiratory Devices Branch (RPDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 868.5630 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NVO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 169 |
| Device | Spacer, Direct Patient Interface |
| Product Code | NVO |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Nebulizer. |
| CFR Regulation Number | 868.5630 [🔎] |