| Primary Device ID | 10705037048564 | 
| NIH Device Record Key | 9e7fee27-c383-4687-88b6-802c822b2174 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Cyclesure | 
| Version Model Number | 14324-30 | 
| Catalog Number | 14324-30 | 
| Company DUNS | 947451626 | 
| Company Name | ADVANCED STERILIZATION PRODUCTS SERVICES INC. | 
| Device Count | 30 | 
| DM Exempt | false | 
| Pre-market Exempt | false | 
| MRI Safety Status | Labeling does not contain MRI Safety Information | 
| Human Cell/Tissue Product | false | 
| Device Kit | false | 
| Device Combination Product | false | 
| Single Use | false | 
| Lot Batch | true | 
| Serial Number | false | 
| Manufacturing Date | false | 
| Expiration Date | true | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | false | 
| OTC Over-The-Counter | true | 
| Phone | +1(888)783-7723 | 
| complaints@aspus.jnj.com | |
| Phone | +1(888)783-7723 | 
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| Phone | +1(888)783-7723 | 
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| Phone | +1(888)783-7723 | 
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| Phone | +1(888)783-7723 | 
| complaints@aspus.jnj.com | |
| Phone | +1(888)783-7723 | 
| complaints@aspus.jnj.com | |
| Phone | +1(888)783-7723 | 
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| Phone | +1(888)783-7723 | 
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| Phone | +1(888)783-7723 | 
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| Phone | +1(888)783-7723 | 
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| Phone | +1(888)783-7723 | 
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| Phone | +1(888)783-7723 | 
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| Phone | +1(888)783-7723 | 
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 | 
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| Phone | +1(888)783-7723 | 
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| Phone | +1(888)783-7723 | 
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| Phone | +1(888)783-7723 | 
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| Phone | +1(888)783-7723 | 
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| Phone | +1(888)783-7723 | 
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| Phone | +1(888)783-7723 | 
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| Phone | +1(888)783-7723 | 
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| Phone | +1(888)783-7723 | 
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| Phone | +1(888)783-7723 | 
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| Phone | +1(888)783-7723 | 
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| Phone | +1(888)783-7723 | 
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| Phone | +1(888)783-7723 | 
| ASP-Complaints@asp.com | 
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *STERRAD® cassettes, or any other oxidizers. | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius | 
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *STERRAD® cassettes, or any other oxidizers. | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius | 
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *STERRAD® cassettes, or any other oxidizers. | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius | 
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *STERRAD® cassettes, or any other oxidizers. | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius | 
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *STERRAD® cassettes, or any other oxidizers. | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius | 
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *STERRAD® cassettes, or any other oxidizers. | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius | 
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *STERRAD® cassettes, or any other oxidizers. | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius | 
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *STERRAD® cassettes, or any other oxidizers. | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius | 
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *STERRAD® cassettes, or any other oxidizers. | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius | 
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *STERRAD® cassettes, or any other oxidizers. | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius | 
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *STERRAD® cassettes, or any other oxidizers. | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius | 
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *STERRAD® cassettes, or any other oxidizers. | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius | 
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *STERRAD® cassettes, or any other oxidizers. | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius | 
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *STERRAD® cassettes, or any other oxidizers. | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius | 
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *STERRAD® cassettes, or any other oxidizers. | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius | 
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *STERRAD® cassettes, or any other oxidizers. | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius | 
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *STERRAD® cassettes, or any other oxidizers. | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius | 
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *STERRAD® cassettes, or any other oxidizers. | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius | 
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *STERRAD® cassettes, or any other oxidizers. | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius | 
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *STERRAD® cassettes, or any other oxidizers. | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius | 
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *STERRAD® cassettes, or any other oxidizers. | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius | 
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *STERRAD® cassettes, or any other oxidizers. | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius | 
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *STERRAD® cassettes, or any other oxidizers. | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius | 
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *STERRAD® cassettes, or any other oxidizers. | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius | 
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *STERRAD® cassettes, or any other oxidizers. | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius | 
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *STERRAD® cassettes, or any other oxidizers. | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius | 
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *STERRAD® cassettes, or any other oxidizers. | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius | 
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *STERRAD® cassettes, or any other oxidizers. | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius | 
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *STERRAD® cassettes, or any other oxidizers. | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius | 
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *STERRAD™ cassettes, or any other oxidizers. | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius | 
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *STERRAD™ cassettes, or any other oxidizers. | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius | 
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *STERRAD™ cassettes, or any other oxidizers. | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius | 
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *STERRAD™ cassettes, or any other oxidizers. | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius | 
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *STERRAD™ cassettes, or any other oxidizers. | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius | 
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *STERRAD™ cassettes, or any other oxidizers. | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius | 
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *STERRAD™ cassettes, or any other oxidizers. | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius | 
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *STERRAD™ cassettes, or any other oxidizers. | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius | 
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *STERRAD™ cassettes, or any other oxidizers. | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius | 
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *STERRAD™ cassettes, or any other oxidizers. | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius | 
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *STERRAD™ cassettes, or any other oxidizers. | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius | 
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *STERRAD™ cassettes, or any other oxidizers. | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius | 
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *STERRAD™ cassettes, or any other oxidizers. | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius | 
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *STERRAD™ cassettes, or any other oxidizers. | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius | 
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *STERRAD™ cassettes, or any other oxidizers. | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 10705037048564 [Primary] | 
| GS1 | 20705037048561 [Package] Package: Case [2 Units] Discontinued: 2025-01-25 Not in Commercial Distribution | 
| GS1 | 80705037048563 [Unit of Use] | 
| FRC | Indicator, biological sterilization process | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 4 | 
| Public Version Date | 2020-12-11 | 
| Device Publish Date | 2016-09-24 | 
| 10705037048564 | Biological Indicator | 
| 20705037016218 | Biological Indicator | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  CYCLESURE  75585456  2825346 Live/Registered | JOHNSON & JOHNSON 1998-11-09 |