FDA.reportPublic FDA data

Cidex

Primary DI
20705037000071
Brand
Cidex
Company
ADVANCED STERILIZATION PRODUCTS SERVICES INC.
Model
20390
Catalog number
20390
Device description
Cidex OPA 1 Gallon
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
MEDSterilant, medical devices

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MEDSterilant, Medical DevicesGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K030004000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K0300040000.55% ORTH-PHTHALALDEHYDE SOLUTIONAdvanced Sterilization Products2003-02-27MED

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705037000071PackageGS14In Commercial Distribution
10705037000074PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503700007120705037000071
1070503700007410705037000074

GMDN Terms#

Term, Definition table
TermDefinition
Medical device disinfection agentA substance containing a chemical agent(s) intended to destroy microorganisms or inhibit their activity (disinfectant) on a medical device (e.g., surgical or dental instrument) and/or facility surface; it may contain surfactants/cleaning agents or enzymes (e.g., protease, lipase, amylase), and may in addition be intended to decalcify equipment. The medical device is intended to be exposed to the substance for a specified period to achieve disinfection, through bathing, wiping, and/or in combination with a disinfection system/unit. It is available in liquid, aerosol, powder, or tablet form; it is not supplied in a dedicated wipe, cap, or other contact-application carrier.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)783-7723complaints@aspus.jnj.com
+1(888)783-7723ASP-Complaints@asp.com

Regulatory Flags#

DUNS number
947451626
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705037048908STERRAD VELOCITY™43210432102017-10-10
10705037049400STERRAD VELOCITY™43210-3043210-302017-10-10
10705037000562EVOTECH™010460101046012018-05-31
10705037045006EVOTECH™010410101041012016-09-24
10705037016495STERRAD™20228202282016-09-24
10705037016198STERRAD™14100141002016-09-24
10705037014132STERRAD NX™10033100332016-09-24
10705037016952STERRAD™21005210052018-05-31
10705037016211Cyclesure14324143242016-09-24
10705037044580CIDEX™226622662016-09-24
10705037012602EVOTECH™8450018450012016-09-24
10705037068753ASP AEROFLEX™911902891190282022-10-25
10705037047611APTIMAX™13839138392016-09-24
10705037071319ULTRA GI™43381433812025-12-15
10705037042999STERRAD™99204992042026-06-03
10705037043002STERRAD™99205992052018-05-31
10705037043019STERRAD™99206992062018-05-31
10705037043026STERRAD™99207992072018-05-31
10705037043033STERRAD™99208992082018-05-31
10705037043040STERRAD™99209992092018-05-31

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Primary DI, Brand, Company table
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