Cyclesure 14324-30

GUDID 10705037048564

Biological Indicator

ADVANCED STERILIZATION PRODUCTS SERVICES INC.

Biological sterilization indicator
Primary Device ID10705037048564
NIH Device Record Key9e7fee27-c383-4687-88b6-802c822b2174
Commercial Distribution StatusIn Commercial Distribution
Brand NameCyclesure
Version Model Number14324-30
Catalog Number14324-30
Company DUNS947451626
Company NameADVANCED STERILIZATION PRODUCTS SERVICES INC.
Device Count30
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+1(888)783-7723
Emailcomplaints@aspus.jnj.com
Phone+1(888)783-7723
Emailcomplaints@aspus.jnj.com
Phone+1(888)783-7723
Emailcomplaints@aspus.jnj.com
Phone+1(888)783-7723
Emailcomplaints@aspus.jnj.com
Phone+1(888)783-7723
Emailcomplaints@aspus.jnj.com
Phone+1(888)783-7723
Emailcomplaints@aspus.jnj.com
Phone+1(888)783-7723
Emailcomplaints@aspus.jnj.com
Phone+1(888)783-7723
Emailcomplaints@aspus.jnj.com
Phone+1(888)783-7723
Emailcomplaints@aspus.jnj.com
Phone+1(888)783-7723
Emailcomplaints@aspus.jnj.com
Phone+1(888)783-7723
Emailcomplaints@aspus.jnj.com
Phone+1(888)783-7723
Emailcomplaints@aspus.jnj.com
Phone+1(888)783-7723
Emailcomplaints@aspus.jnj.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near any sterilizer, sources of ethylene oxide, hydrogen peroxide, acids, alkalis or volatile antimicrobials such as glutaraldehyde or formaldehyde,
Special Storage Condition, SpecifyBetween 0 and 0 *STERRAD® cassettes, or any other oxidizers.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near any sterilizer, sources of ethylene oxide, hydrogen peroxide, acids, alkalis or volatile antimicrobials such as glutaraldehyde or formaldehyde,
Special Storage Condition, SpecifyBetween 0 and 0 *STERRAD® cassettes, or any other oxidizers.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near any sterilizer, sources of ethylene oxide, hydrogen peroxide, acids, alkalis or volatile antimicrobials such as glutaraldehyde or formaldehyde,
Special Storage Condition, SpecifyBetween 0 and 0 *STERRAD® cassettes, or any other oxidizers.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near any sterilizer, sources of ethylene oxide, hydrogen peroxide, acids, alkalis or volatile antimicrobials such as glutaraldehyde or formaldehyde,
Special Storage Condition, SpecifyBetween 0 and 0 *STERRAD® cassettes, or any other oxidizers.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near any sterilizer, sources of ethylene oxide, hydrogen peroxide, acids, alkalis or volatile antimicrobials such as glutaraldehyde or formaldehyde,
Special Storage Condition, SpecifyBetween 0 and 0 *STERRAD® cassettes, or any other oxidizers.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near any sterilizer, sources of ethylene oxide, hydrogen peroxide, acids, alkalis or volatile antimicrobials such as glutaraldehyde or formaldehyde,
Special Storage Condition, SpecifyBetween 0 and 0 *STERRAD® cassettes, or any other oxidizers.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near any sterilizer, sources of ethylene oxide, hydrogen peroxide, acids, alkalis or volatile antimicrobials such as glutaraldehyde or formaldehyde,
Special Storage Condition, SpecifyBetween 0 and 0 *STERRAD® cassettes, or any other oxidizers.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near any sterilizer, sources of ethylene oxide, hydrogen peroxide, acids, alkalis or volatile antimicrobials such as glutaraldehyde or formaldehyde,
Special Storage Condition, SpecifyBetween 0 and 0 *STERRAD® cassettes, or any other oxidizers.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near any sterilizer, sources of ethylene oxide, hydrogen peroxide, acids, alkalis or volatile antimicrobials such as glutaraldehyde or formaldehyde,
Special Storage Condition, SpecifyBetween 0 and 0 *STERRAD® cassettes, or any other oxidizers.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near any sterilizer, sources of ethylene oxide, hydrogen peroxide, acids, alkalis or volatile antimicrobials such as glutaraldehyde or formaldehyde,
Special Storage Condition, SpecifyBetween 0 and 0 *STERRAD® cassettes, or any other oxidizers.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near any sterilizer, sources of ethylene oxide, hydrogen peroxide, acids, alkalis or volatile antimicrobials such as glutaraldehyde or formaldehyde,
Special Storage Condition, SpecifyBetween 0 and 0 *STERRAD® cassettes, or any other oxidizers.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near any sterilizer, sources of ethylene oxide, hydrogen peroxide, acids, alkalis or volatile antimicrobials such as glutaraldehyde or formaldehyde,
Special Storage Condition, SpecifyBetween 0 and 0 *STERRAD® cassettes, or any other oxidizers.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near any sterilizer, sources of ethylene oxide, hydrogen peroxide, acids, alkalis or volatile antimicrobials such as glutaraldehyde or formaldehyde,
Special Storage Condition, SpecifyBetween 0 and 0 *STERRAD® cassettes, or any other oxidizers.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near any sterilizer, sources of ethylene oxide, hydrogen peroxide, acids, alkalis or volatile antimicrobials such as glutaraldehyde or formaldehyde,
Special Storage Condition, SpecifyBetween 0 and 0 *STERRAD® cassettes, or any other oxidizers.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near any sterilizer, sources of ethylene oxide, hydrogen peroxide, acids, alkalis or volatile antimicrobials such as glutaraldehyde or formaldehyde,
Special Storage Condition, SpecifyBetween 0 and 0 *STERRAD® cassettes, or any other oxidizers.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near any sterilizer, sources of ethylene oxide, hydrogen peroxide, acids, alkalis or volatile antimicrobials such as glutaraldehyde or formaldehyde,
Special Storage Condition, SpecifyBetween 0 and 0 *STERRAD® cassettes, or any other oxidizers.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near any sterilizer, sources of ethylene oxide, hydrogen peroxide, acids, alkalis or volatile antimicrobials such as glutaraldehyde or formaldehyde,
Special Storage Condition, SpecifyBetween 0 and 0 *STERRAD® cassettes, or any other oxidizers.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near any sterilizer, sources of ethylene oxide, hydrogen peroxide, acids, alkalis or volatile antimicrobials such as glutaraldehyde or formaldehyde,
Special Storage Condition, SpecifyBetween 0 and 0 *STERRAD® cassettes, or any other oxidizers.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near any sterilizer, sources of ethylene oxide, hydrogen peroxide, acids, alkalis or volatile antimicrobials such as glutaraldehyde or formaldehyde,
Special Storage Condition, SpecifyBetween 0 and 0 *STERRAD® cassettes, or any other oxidizers.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near any sterilizer, sources of ethylene oxide, hydrogen peroxide, acids, alkalis or volatile antimicrobials such as glutaraldehyde or formaldehyde,
Special Storage Condition, SpecifyBetween 0 and 0 *STERRAD® cassettes, or any other oxidizers.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near any sterilizer, sources of ethylene oxide, hydrogen peroxide, acids, alkalis or volatile antimicrobials such as glutaraldehyde or formaldehyde,
Special Storage Condition, SpecifyBetween 0 and 0 *STERRAD® cassettes, or any other oxidizers.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near any sterilizer, sources of ethylene oxide, hydrogen peroxide, acids, alkalis or volatile antimicrobials such as glutaraldehyde or formaldehyde,
Special Storage Condition, SpecifyBetween 0 and 0 *STERRAD® cassettes, or any other oxidizers.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near any sterilizer, sources of ethylene oxide, hydrogen peroxide, acids, alkalis or volatile antimicrobials such as glutaraldehyde or formaldehyde,
Special Storage Condition, SpecifyBetween 0 and 0 *STERRAD® cassettes, or any other oxidizers.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near any sterilizer, sources of ethylene oxide, hydrogen peroxide, acids, alkalis or volatile antimicrobials such as glutaraldehyde or formaldehyde,
Special Storage Condition, SpecifyBetween 0 and 0 *STERRAD® cassettes, or any other oxidizers.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near any sterilizer, sources of ethylene oxide, hydrogen peroxide, acids, alkalis or volatile antimicrobials such as glutaraldehyde or formaldehyde,
Special Storage Condition, SpecifyBetween 0 and 0 *STERRAD® cassettes, or any other oxidizers.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near any sterilizer, sources of ethylene oxide, hydrogen peroxide, acids, alkalis or volatile antimicrobials such as glutaraldehyde or formaldehyde,
Special Storage Condition, SpecifyBetween 0 and 0 *STERRAD® cassettes, or any other oxidizers.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near any sterilizer, sources of ethylene oxide, hydrogen peroxide, acids, alkalis or volatile antimicrobials such as glutaraldehyde or formaldehyde,
Special Storage Condition, SpecifyBetween 0 and 0 *STERRAD® cassettes, or any other oxidizers.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near any sterilizer, sources of ethylene oxide, hydrogen peroxide, acids, alkalis or volatile antimicrobials such as glutaraldehyde or formaldehyde,
Special Storage Condition, SpecifyBetween 0 and 0 *STERRAD® cassettes, or any other oxidizers.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near any sterilizer, sources of ethylene oxide, hydrogen peroxide, acids, alkalis or volatile antimicrobials such as glutaraldehyde or formaldehyde,
Special Storage Condition, SpecifyBetween 0 and 0 *STERRAD® cassettes, or any other oxidizers.
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110705037048564 [Primary]
GS180705037048563 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRCIndicator, biological sterilization process

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-12-11
Device Publish Date2016-09-24

On-Brand Devices [Cyclesure]

10705037048564Biological Indicator
20705037016218Biological Indicator

Trademark Results [Cyclesure]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CYCLESURE
CYCLESURE
75585456 2825346 Live/Registered
JOHNSON & JOHNSON
1998-11-09

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