Part B: SUPPLEMENTARY INFORMATION
AAMI / ANSI , . () |
| 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 |
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| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) | | |
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| Devices Affected: |
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| Processes Affected: |
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| Type of Standard: |
| Vertical, National |
| 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 |
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 |
| |
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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| 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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