Recognition List Number: 028 Publication Date: 03/16/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 9-69: AAMI / ANSI / ISO 13959:2009, Water for hemodialysis and related therapies. (ObGyn/Gastroenterology)
Date of Standard: 2009. |
| Addresses of Standards Organizations: |
| Association for the Advancement of Medical Instrumentation (AAMI) |
| 4301 North Fairfax Drive |
| Suite 301 |
| Arlington, VA 22203 |
| |
| American National Standards Institute (ANSI) |
| 25 West 43rd Street |
| 4th Floor |
| New York, NY 10036 |
| |
| 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) | | DIVISION OF REPRODUCTIVE, GASTRORENAL AND UROLOGY DEVICES (DRGUD) |
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| Devices Affected: |
| Hemodialysis Water Purification Systems for Dialysis, Hemodialysis Systems |
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| Processes Affected: |
| 510(k), PMA, PDP, IDE, HDE, Quality System Regulations |
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| Type of Standard: |
| Vertical, National |
| Extent of Recognition: |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §876.5665 |
Disinfectant, Subsystem, Water Purification |
Class 2 |
NIH |
| §876.5665 |
Subsystem, Water Purification |
Class 2 |
FIP |
| §876.5665 |
System, Water Purification, General Medical Use |
Class 2 |
NHV |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §876.5820 |
Dialysate Concentrate For Hemodialysis (Liquid Or Powder) |
Class 2 |
KPO |
| §876.5820 |
Meter, Conductivity, Induction, Remote Type |
Class 2 |
FLB |
| §876.5820 |
Set, Dialysis, Single Needle With Uni-Directional Pump |
Class 2 |
FIF |
| §876.5820 |
Set, Dialysis, Single Needle With Uni-Directional Pump, Reprocessed |
Class 2 |
NNG |
| §876.5820 |
Solution-Test Standard-Conductivity, Dialysis |
Class 2 |
FKH |
| §876.5820 |
Strip, Dialysate Ph Indicator |
Class 2 |
MNV |
| §876.5820 |
Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator |
Class 2 |
NTZ |
| §876.5820 |
Subsystem, Proportioning |
Class 2 |
FKR |
| §876.5820 |
System, Dialysate Delivery, Central Multiple Patient |
Class 2 |
FKQ |
| §876.5820 |
System, Dialysate Delivery, Recirculating |
Class 2 |
FIK |
| §876.5820 |
System, Dialysate Delivery, Recirculating, Single Pass |
Class 2 |
FIJ |
| §876.5820 |
System, Dialysate Delivery, Single Pass |
Class 2 |
FIL |
| §876.5820 |
System, Dialysate Delivery, Single Patient |
Class 2 |
FKP |
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Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §876.5860 |
Disinfectant, Dialysate Delivery System |
Class 2 |
NII |
| §876.5860 |
System, Dialysate Delivery, Sealed |
Class 2 |
FII |
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| Relevant Guidance: |
Guidance for the Content of Premarket Nofitications for Water Purification Components and Systems for Hemodialysis. Issued May 30, 1997.
Regulatory Status of Disinfectants Used to Process Dialysate Delivery Systems and Water Purification Systems for Hemodialysis; Guidance for Industry and FDA. Issued August 30, 2002 |
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| FDA Technical Contacts: |
| Gema Gonzalez |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room G220 |
| Silver Spring MD 20993 |
| 301/796-6519 |
| Email: gema.gonzalez@fda.hhs.gov |
|
| Carolyn Neuland |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room G226 |
| Silver Spring MD 20993 |
| 301/796-6523 |
| Email: carolyn.neuland@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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