Cyclesure 14324
GUDID 20705037016218
Biological Indicator
ADVANCED STERILIZATION PRODUCTS SERVICES INC.
Biological sterilization indicator| Primary Device ID | 20705037016218 |
| NIH Device Record Key | 3ff38281-28ae-43ad-a5e2-c6f3fcd8d295 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cyclesure |
| Version Model Number | 14324 |
| Catalog Number | 14324 |
| Company DUNS | 947451626 |
| Company Name | ADVANCED STERILIZATION PRODUCTS SERVICES INC. |
| Device Count | 60 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
Customer Support Contacts
| Phone | +1(888)783-7723 |
| complaints@aspus.jnj.com | |
| Phone | +1(888)783-7723 |
| complaints@aspus.jnj.com | |
| Phone | +1(888)783-7723 |
| complaints@aspus.jnj.com | |
| Phone | +1(888)783-7723 |
| complaints@aspus.jnj.com | |
| Phone | +1(888)783-7723 |
| complaints@aspus.jnj.com | |
| Phone | +1(888)783-7723 |
| complaints@aspus.jnj.com | |
| Phone | +1(888)783-7723 |
| complaints@aspus.jnj.com | |
| Phone | +1(888)783-7723 |
| complaints@aspus.jnj.com | |
| Phone | +1(888)783-7723 |
| complaints@aspus.jnj.com | |
| Phone | +1(888)783-7723 |
| complaints@aspus.jnj.com | |
| Phone | +1(888)783-7723 |
| complaints@aspus.jnj.com | |
| Phone | +1(888)783-7723 |
| complaints@aspus.jnj.com | |
| Phone | +1(888)783-7723 |
| complaints@aspus.jnj.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com |
Operating and Storage Conditions
| 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,STERRAD® cassettes, |
| Special Storage Condition, Specify | Between 0 and 0 *or any other oxidizers.Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator. |
| 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,STERRAD® cassettes, |
| Special Storage Condition, Specify | Between 0 and 0 *or any other oxidizers.Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator. |
| 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,STERRAD® cassettes, |
| Special Storage Condition, Specify | Between 0 and 0 *or any other oxidizers.Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator. |
| 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,STERRAD® cassettes, |
| Special Storage Condition, Specify | Between 0 and 0 *or any other oxidizers.Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator. |
| 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,STERRAD® cassettes, |
| Special Storage Condition, Specify | Between 0 and 0 *or any other oxidizers.Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator. |
| 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,STERRAD® cassettes, |
| Special Storage Condition, Specify | Between 0 and 0 *or any other oxidizers.Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator. |
| 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,STERRAD® cassettes, |
| Special Storage Condition, Specify | Between 0 and 0 *or any other oxidizers.Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator. |
| 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,STERRAD® cassettes, |
| Special Storage Condition, Specify | Between 0 and 0 *or any other oxidizers.Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator. |
| 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,STERRAD® cassettes, |
| Special Storage Condition, Specify | Between 0 and 0 *or any other oxidizers.Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator. |
| 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,STERRAD® cassettes, |
| Special Storage Condition, Specify | Between 0 and 0 *or any other oxidizers.Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator. |
| 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,STERRAD® cassettes, |
| Special Storage Condition, Specify | Between 0 and 0 *or any other oxidizers.Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator. |
| 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,STERRAD® cassettes, |
| Special Storage Condition, Specify | Between 0 and 0 *or any other oxidizers.Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator. |
| 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,STERRAD® cassettes, |
| Special Storage Condition, Specify | Between 0 and 0 *or any other oxidizers.Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator. |
| 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,STERRAD® cassettes, |
| Special Storage Condition, Specify | Between 0 and 0 *or any other oxidizers.Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator. |
| 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,STERRAD® cassettes, |
| Special Storage Condition, Specify | Between 0 and 0 *or any other oxidizers.Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator. |
| 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,STERRAD® cassettes, |
| Special Storage Condition, Specify | Between 0 and 0 *or any other oxidizers.Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator. |
| 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,STERRAD® cassettes, |
| Special Storage Condition, Specify | Between 0 and 0 *or any other oxidizers.Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator. |
| 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,STERRAD® cassettes, |
| Special Storage Condition, Specify | Between 0 and 0 *or any other oxidizers.Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator. |
| 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,STERRAD® cassettes, |
| Special Storage Condition, Specify | Between 0 and 0 *or any other oxidizers.Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator. |
| 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,STERRAD® cassettes, |
| Special Storage Condition, Specify | Between 0 and 0 *or any other oxidizers.Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator. |
| 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,STERRAD® cassettes, |
| Special Storage Condition, Specify | Between 0 and 0 *or any other oxidizers.Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator. |
| 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,STERRAD® cassettes, |
| Special Storage Condition, Specify | Between 0 and 0 *or any other oxidizers.Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator. |
| 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,STERRAD® cassettes, |
| Special Storage Condition, Specify | Between 0 and 0 *or any other oxidizers.Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator. |
| 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,STERRAD® cassettes, |
| Special Storage Condition, Specify | Between 0 and 0 *or any other oxidizers.Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator. |
| 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,STERRAD® cassettes, |
| Special Storage Condition, Specify | Between 0 and 0 *or any other oxidizers.Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator. |
| 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,STERRAD® cassettes, |
| Special Storage Condition, Specify | Between 0 and 0 *or any other oxidizers.Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator. |
| 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,STERRAD® cassettes, |
| Special Storage Condition, Specify | Between 0 and 0 *or any other oxidizers.Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator. |
| 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,STERRAD® cassettes, |
| Special Storage Condition, Specify | Between 0 and 0 *or any other oxidizers.Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator. |
| 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,STERRAD® cassettes, |
| Special Storage Condition, Specify | Between 0 and 0 *or any other oxidizers.Do not spill solvents such as IPA or Acetone on the tape as the solvents may dissolve the chemical indicator. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10705037016211 [Primary] |
| GS1 | 20705037016218 [Package] Contains: 10705037016211 Package: Case [4 Units] In Commercial Distribution |
| GS1 | 80705037016210 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K103222
FDA Product Code
| FRC | Indicator, biological sterilization process |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-12-11 |
| Device Publish Date | 2016-09-24 |
On-Brand Devices [Cyclesure]
| 10705037048564 | Biological Indicator |
| 20705037016218 | Biological Indicator |
Trademark Results [Cyclesure]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CYCLESURE 75585456 2825346 Live/Registered |
JOHNSON & JOHNSON 1998-11-09 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.