Recognition List Number: 028 Publication Date: 03/16/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 1-62: ISO 5356-1 Third edition 2004-05-15, Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets. (Anesthesias)
Date of Standard: 2004. |
| Address of Standards Organization: |
| International Organization for Standardization (ISO)* |
| 1, Rue de Varembe |
| Case Postale 56 |
| CH 1211 Geneva 20, 0 |
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SWITZERLAND
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| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) | | |
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| Devices Affected: |
| Anaesthetic and respiratory equipment -- conical connectors. Breathing circuits, ventilator tubing, tracheal tubes, tracheostomy tubes, bronchial tubes, PEEP valves, anesthesia gas machines, ventilators, manual emergency ventilators, powered emergency ventilators, airway connectors, bacterial filters, respiratory gas humidifiers, airway connectors and nonrebreathing valves. |
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| Processes Affected: |
| 510(k), PMA, IDE, PDP, HDE, Design Control Input |
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| Type of Standard: |
| International, Vertical |
| Extent of Recognition: |
| Complete standard and any annexes. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §868.5160 |
Gas-Machine, Anesthesia |
Class 2 |
BSZ |
| §868.5160 |
Gas-Machine, Anesthesia |
Class 2 |
BSZ |
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Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §868.5240 |
Circuit, Breathing (W Connector, Adaptor, Y Piece) |
Class 1 |
CAI |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §868.5260 |
Filter, Bacterial, Breathing-Circuit |
Class 2 |
CAH |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §868.5375 |
Condenser, Heat And Moisture (Artificial Nose) |
Class 1 |
BYD |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §868.5450 |
Humidifier, Respiratory Gas, (Direct Patient Interface) |
Class 2 |
BTT |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §868.5720 |
Tube, Bronchial (W/Wo Connector) |
Class 2 |
BTS |
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Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §868.5730 |
Tube, Tracheal (W/Wo Connector) |
Class 2 |
BTR |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §868.5740 |
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) |
Class 2 |
CBI |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §868.5800 |
Tube Tracheostomy And Tube Cuff |
Class 2 |
JOH |
| §868.5800 |
Tube, Tracheostomy (W/Wo Connector) |
Class 2 |
BTO |
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Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §868.5810 |
Connector, Airway (Extension) |
Class 1 |
BZA |
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Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §868.5870 |
Valve, Non-Rebreathing |
Class 2 |
CBP |
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Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §868.5895 |
Ventilator, Continuous, Facility Use |
Class 2 |
CBK |
| §868.5895 |
Ventilator, Continuous, Minimal Ventilatory Support,Facility Use |
Class 2 |
MNT |
| §868.5895 |
Ventilator, Continuous, Non-Life-Supporting |
Class 2 |
MNS |
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Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §868.5905 |
Ventilator, Non-Continuous (Respirator) |
Class 2 |
BZD |
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Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §868.5915 |
Ventilator, Emergency, Manual (Resuscitator) |
Class 2 |
BTM |
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Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §868.5925 |
Ventilator, Emergency, Powered (Resuscitator) |
Class 2 |
BTL |
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Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §868.5965 |
Attachment, Breathing, Positive End Expiratory Pressure |
Class 2 |
BYE |
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Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §868.5975 |
Set, Tubing And Support, Ventilator (W Harness) |
Class 1 |
BZO |
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| Relevant Guidance: |
Draft Reviewer Guidance on Face Masks and Shield for CPR, March 1994
Draft reviewer guidance for ventilators July 1995
Guidance for Oxygen Conserving Device 510(k) Review 73 BZD 868.5905 Non-continuous Ventilator Class II, February 1989
Draft Emergency Resuscitator Guidance, April 14, 1993 |
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| FDA Technical Contact: |
| Nayan Patel |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 2550 |
| Silver Spring MD 20993 |
| 301/796-4110 |
| Email: nayan.patel@fda.hhs.gov |
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| * In the United States, copies of this standard can be obtained from: |
| American National Standards Institute (ANSI)* |
| 25 West 43rd Street |
| 4th Floor |
| New York, NY 10036 |
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