FDA Registration
Active
🇺🇸 United States
ADVANCED STERILIZATION PRODUCTS
Reg #: 2084725
·
FEI: 3003662624
·
Expires 2026
Products
14
Proprietary Names
43
Establishment Types
5
Classifications
14
Registration Details
- Registration Name
- ADVANCED STERILIZATION PRODUCTS
- Registration Number
- 2084725
- FEI Number
- 3003662624
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 33 TECHNOLOGY DRIVE
- City
- Irvine
- State
- CA
- ZIP
- 92618
- Country
- US
Regulatory Submissions
- 510(k) Number
- K023290
Owner / Operator
- Firm Name
- Advanced Sterilization Products
- Operator Number
- 9068155
- Address
- 33 Technology Drive, --
- City
- Irvine
- State
- CA
- Postal Code
- 92618
- Country
- US
- Correspondent
- Brent Lewis
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sterilizer, Ethylene-Oxide Gas | FLF | Class 2 | General Hospital | No | 2008-05-06 |
| Sterilizer, Chemical | MLR | Class 2 | General Hospital | No | 2012-11-01 |
| Indicator, Physical/Chemical Sterilization Process | JOJ | Class 2 | General Hospital | No | 2008-01-10 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2017-07-19 |
| Table, Mechanical | INW | Class 1 | Physical Medicine | No | 2013-02-01 |
| Cleaner, Ultrasonic, Medical Instrument | FLG | Class 1 | General Hospital | No | 2021-02-11 |
| Indicator, Biological Sterilization Process | FRC | Class 2 | General Hospital | No | 2024-09-23 |
| Bath, Incubators/Water, All | JTQ | Class 1 | Microbiology | No | 2016-03-31 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2013-02-01 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2017-08-21 |
| Wrap, Sterilization | FRG | Class 2 | General Hospital | No | 2024-09-18 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2013-02-01 |
| Accessories, Cleaning, For Endoscope | FEB | Class 2 | Gastroenterology, Urology | No | 2015-04-14 |
| Sterilant, Medical Devices | MED | Class 2 | General Hospital | No | 2019-05-07 |
Proprietary Names
STERRAD 100S Sterilizer and Cassette (10101, 10113)
STERRAD 100NX System DUO Cycle Upgrade Kit (10144, 10104, 10104-002,003,004)
STERRAD 100NX w ALLClear Technology (10144, 10104ACSW, 10104-005,-006,-007,-008)
STERRAD SEALSURE Chemical Indicator (14100)
STERRAD SEALSURE Chemical Indicator Tape (Non-Latex 14202NL)
ASP ACCESS (53001)
STERRAD NX System Cart (10300)
Enzol (2252, 2257), Cidezyme (2258, 2260), Cidezyme XTRA (22591 ) AEROZYME XTRA (22520)
STERRAD NX Cassette (10133)
STERRAD SEALSURE Chemical Indicator (CI) Tape (14202NL)
STERRAD VELOCITY Biological Indicator (BI) 60 Count (43210)
STERRAD VELOCITY Reader (43220)
STERRAD Chemical Indicator (CI) Strip (14100)
STERRAD VELOCITY Biological Indicator (BI) 30 Count (43210-30)
ULTRA GI Cycle Validation Kit (43380)
ULTRA GI Process Challenge Device (PCD) Vial (43400)
Incubator
ASP CIDEX Plus Solution Test Strips
APTIMAX Instrument Tray Holders (994XX)
STERRAD VELOCITY Biological Indicator and Reader (43210, 43210-30, 43220)
Tyvek Pouch/Roll with STERRAD Chemical Indicator (123XX, 124XX, 125XX)
STERRAD Chemical Indicator Strip (14100)
STERRAD 100NX Sterilizer with ALLClear Technology and ULTRA GI Cycle (10104-009, 10104-010)
APTIMAX Instrument Tray for ULTRA GI Cycle (011077)
STERRAD SEALSURE Chemical Indicator Tape (14202)
STERRAD 100NX Sterilizer and Cassette (10104, 10104-002, 10144)
STERRAD Sterilization Pouch ( 120XX, 127XX)
STERRAD Instrument Tray Mats (992XX)
STERRAD NX Test Pack (20239)
STERRAD 100 NX EXPRESS Test Pack (20123)
STERRAD 100NX Sterilization System with ALLClear Technology (10144,10104ACSW, 10104-005,10104-006, 10104-007, 10104-008)
STERRAD 100NX Test Pack Kit (20243)
STERRAD VELOCITY BI/PCD (30 and 60 Count), STERRAD VELOCITY READER (43210,43220)
STERRAD NX and 100NX with DTI Connectivity (DTINX, DTI100NX)
EVOTECH ECR (50004)
STERRAD SealSure Chemical Indicator Tape (14202)
STERRAD NX Sterilization System with ALLClear Technology (10133, 10033-004, 10033ACSW)
STERRAD 100NX System EXPRESS Cycle (10144,10104,10104-002)
STERRAD NX System w ALLClear Technology (10133, 10033ACSW, 10033-004)
Aptimax Instrument Tray (138XX)
EvoTech Integrated Endoscope Disinfection System (50004)
AEROFLEX AER, AUTOSURE MRC Reagent, AEROZYME and AERO-OPA (28000, 23300, 25520, 25410)
STERRAD Velocity Validation Kit (43230, 43330, 43340, 43360, 43390)
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Remanufacture Medical Device