Recognition List Number: 022 Publication Date: 09/08/2009
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 1-81: CGA V-5:2008, Diameter-Index Safety System (Noninterchangeable Low Pressure Connections for Medical Gas Applications. (Anesthesias)
Date of Standard: 2008. |
| Address of Standards Organization: |
| Compressed Gas Associated, Incorporated (CGA) |
| 1725 Jefferson Davis Highway |
| Suite 1004 |
| Arlington, VA 22202-4102 |
| |
|
| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) | | |
|
|
| Devices Affected: |
| Devices connected to low pressure medical gases or have low pressure outlets. |
|
| Processes Affected: |
| 510(k), PMA, IDE, PDP, HDE, Design Control Input |
|
| Type of Standard: |
| National, Vertical |
| Extent of Recognition: |
| Complete standard and any annexes. |
|
| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §868.2700 |
Regulator, Pressure, Gas Cylinder |
Class 1 |
CAN |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §868.5160 |
Gas-Machine, Anesthesia |
Class 2 |
BSZ |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §868.5925 |
Ventilator, Emergency, Powered (Resuscitator) |
Class 2 |
BTL |
| |
|
| Relevant Guidance: |
Draft Emergency Resuscitator Guidance, April 1993
Draft Reviewer Guidance for Ventilators, July 1995 |
|
| FDA Technical Contact: |
| Christy Foreman |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 1676 |
| Silver Spring MD 20993 |
| 301/796-6382 |
| Email: christy.foreman@fda.hhs.gov |
|
|
