Sterilucent™ Process Challenge Device PCD-F for HC 80TT Flexible Cycle SL291
GUDID 00850012210078
STERILUCENT, INC.
Biological sterilization indicator| Primary Device ID | 00850012210078 |
| NIH Device Record Key | 3711cb71-a485-46dc-9273-e7951ee92d84 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sterilucent™ Process Challenge Device PCD-F for HC 80TT Flexible Cycle |
| Version Model Number | SL291 |
| Catalog Number | SL291 |
| Company DUNS | 005634969 |
| Company Name | STERILUCENT, INC. |
| Device Count | 25 |
| 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 | false |
Customer Support Contacts
| Phone | 1-877-721-8405 |
| CustomerService@Sterilucent.com | |
| Phone | 1-877-721-8405 |
| CustomerService@Sterilucent.com | |
| Phone | 1-877-721-8405 |
| CustomerService@Sterilucent.com | |
| Phone | 1-877-721-8405 |
| CustomerService@Sterilucent.com | |
| Phone | 1-877-721-8405 |
| CustomerService@Sterilucent.com | |
| Phone | 1-877-721-8405 |
| CustomerService@Sterilucent.com | |
| Phone | 1-877-721-8405 |
| CustomerService@Sterilucent.com | |
| Phone | 1-877-721-8405 |
| CustomerService@Sterilucent.com | |
| Phone | 1-877-721-8405 |
| CustomerService@Sterilucent.com | |
| Phone | 1-877-721-8405 |
| CustomerService@Sterilucent.com | |
| Phone | 1-877-721-8405 |
| CustomerService@Sterilucent.com | |
| Phone | 1-877-721-8405 |
| CustomerService@Sterilucent.com | |
| Phone | 1-877-721-8405 |
| CustomerService@Sterilucent.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *• Do not store near any sterilizer; sources of ethylene oxide or hydrogen peroxide; alkalis, acids, or oxidizers; volatile antimicrobials such as glutaraldehyde or formaldehyde; and sterilant packages |
| Storage Environment Humidity | Between 60 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight or any other form of UV light. |
| Special Storage Condition, Specify | Between 0 and 0 *• Do not store near any sterilizer; sources of ethylene oxide or hydrogen peroxide; alkalis, acids, or oxidizers; volatile antimicrobials such as glutaraldehyde or formaldehyde; and sterilant packages |
| Storage Environment Humidity | Between 60 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight or any other form of UV light. |
| Special Storage Condition, Specify | Between 0 and 0 *• Do not store near any sterilizer; sources of ethylene oxide or hydrogen peroxide; alkalis, acids, or oxidizers; volatile antimicrobials such as glutaraldehyde or formaldehyde; and sterilant packages |
| Storage Environment Humidity | Between 60 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight or any other form of UV light. |
| Special Storage Condition, Specify | Between 0 and 0 *• Do not store near any sterilizer; sources of ethylene oxide or hydrogen peroxide; alkalis, acids, or oxidizers; volatile antimicrobials such as glutaraldehyde or formaldehyde; and sterilant packages |
| Storage Environment Humidity | Between 60 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight or any other form of UV light. |
| Special Storage Condition, Specify | Between 0 and 0 *• Do not store near any sterilizer; sources of ethylene oxide or hydrogen peroxide; alkalis, acids, or oxidizers; volatile antimicrobials such as glutaraldehyde or formaldehyde; and sterilant packages |
| Storage Environment Humidity | Between 60 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight or any other form of UV light. |
| Special Storage Condition, Specify | Between 0 and 0 *• Do not store near any sterilizer; sources of ethylene oxide or hydrogen peroxide; alkalis, acids, or oxidizers; volatile antimicrobials such as glutaraldehyde or formaldehyde; and sterilant packages |
| Storage Environment Humidity | Between 60 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight or any other form of UV light. |
| Special Storage Condition, Specify | Between 0 and 0 *• Do not store near any sterilizer; sources of ethylene oxide or hydrogen peroxide; alkalis, acids, or oxidizers; volatile antimicrobials such as glutaraldehyde or formaldehyde; and sterilant packages |
| Storage Environment Humidity | Between 60 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight or any other form of UV light. |
| Special Storage Condition, Specify | Between 0 and 0 *• Do not store near any sterilizer; sources of ethylene oxide or hydrogen peroxide; alkalis, acids, or oxidizers; volatile antimicrobials such as glutaraldehyde or formaldehyde; and sterilant packages |
| Storage Environment Humidity | Between 60 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight or any other form of UV light. |
| Special Storage Condition, Specify | Between 0 and 0 *• Do not store near any sterilizer; sources of ethylene oxide or hydrogen peroxide; alkalis, acids, or oxidizers; volatile antimicrobials such as glutaraldehyde or formaldehyde; and sterilant packages |
| Storage Environment Humidity | Between 60 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight or any other form of UV light. |
| Special Storage Condition, Specify | Between 0 and 0 *• Do not store near any sterilizer; sources of ethylene oxide or hydrogen peroxide; alkalis, acids, or oxidizers; volatile antimicrobials such as glutaraldehyde or formaldehyde; and sterilant packages |
| Storage Environment Humidity | Between 60 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight or any other form of UV light. |
| Special Storage Condition, Specify | Between 0 and 0 *• Do not store near any sterilizer; sources of ethylene oxide or hydrogen peroxide; alkalis, acids, or oxidizers; volatile antimicrobials such as glutaraldehyde or formaldehyde; and sterilant packages |
| Storage Environment Humidity | Between 60 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight or any other form of UV light. |
| Special Storage Condition, Specify | Between 0 and 0 *• Do not store near any sterilizer; sources of ethylene oxide or hydrogen peroxide; alkalis, acids, or oxidizers; volatile antimicrobials such as glutaraldehyde or formaldehyde; and sterilant packages |
| Storage Environment Humidity | Between 60 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight or any other form of UV light. |
| Special Storage Condition, Specify | Between 0 and 0 *• Do not store near any sterilizer; sources of ethylene oxide or hydrogen peroxide; alkalis, acids, or oxidizers; volatile antimicrobials such as glutaraldehyde or formaldehyde; and sterilant packages |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850012210078 [Unit of Use] |
| GS1 | 00850012210085 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K192001
FDA Product Code
| FRC | Indicator, Biological Sterilization Process |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-05-07 |
| Device Publish Date | 2020-04-29 |
Devices Manufactured by STERILUCENT, INC.
| 00850012210030 - Sterilucent™ Sterilant Disc | 2020-05-07 |
| 00850012210054 - Sterilucent™ Process Challenge Device PCD-L for HC 80TT Lumen Cycle | 2020-05-07 |
| 00850012210078 - Sterilucent™ Process Challenge Device PCD-F for HC 80TT Flexible Cycle | 2020-05-07 |
| 00850012210078 - Sterilucent™ Process Challenge Device PCD-F for HC 80TT Flexible Cycle | 2020-05-07 |
| 00850012210009 - Sterilucent™ HC 80TT Hydrogen Peroxide Sterilizer 120V | 2020-05-06 |
Trademark Results [Sterilucent]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STERILUCENT 77824014 4238030 Live/Registered |
Sterilucent, Inc. 2009-09-10 |
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