Revital-Ox PCC081
GUDID 50724995217360
The Revital-Ox PAA High Level Disinfectant Chemical Indicator is used for the routine monitoring of enspire 300 Series Automated Endoscope Reprocessor employing Revital-Ox PAA High Level Disinfectant.
ALBERT BROWNE LIMITED
Peracetic acid device disinfectant/sterilant test strip| Primary Device ID | 50724995217360 |
| NIH Device Record Key | e49d7131-84bd-4731-9a94-eb2e69d1a244 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Revital-Ox |
| Version Model Number | PCC081 |
| Catalog Number | PCC081 |
| Company DUNS | 218172765 |
| Company Name | ALBERT BROWNE LIMITED |
| Device Count | 50 |
| 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 | 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 |
Customer Support Contacts
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx |
Operating and Storage Conditions
| Storage Environment Temperature | Between 43 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from direct light |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 43 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from direct light |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 43 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from direct light |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 43 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from direct light |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 43 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from direct light |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 43 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from direct light |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 43 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from direct light |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 43 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from direct light |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 43 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from direct light |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 43 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from direct light |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 43 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from direct light |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 43 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from direct light |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 43 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from direct light |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 43 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from direct light |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 43 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from direct light |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 43 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from direct light |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 43 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from direct light |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 43 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from direct light |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 43 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from direct light |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 43 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from direct light |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 43 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from direct light |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 43 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Keep away from direct light |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00724995217365 [Unit of Use] |
| GS1 | 10724995217362 [Primary] |
| GS1 | 50724995217360 [Package] Contains: 10724995217362 Package: Box [2 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K230558
FDA Product Code
| JOJ | Indicator, physical/chemical 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 | 2023-09-08 |
| Device Publish Date | 2023-08-31 |
Devices Manufactured by ALBERT BROWNE LIMITED
| 50724995229547 - Celerity | 2024-04-30 Celerity Chemical Indicator for enspire 3000 CLCSPS employing S40 Sterilant. |
| 50724995229493 - VERIFY | 2024-04-16 VERIFY Chemical Indicator for SYSTEM 1E and SYSTEM 1 endo Liquid Chemical Sterilant Processing Systems |
| 50724995217360 - Revital-Ox | 2023-09-08The Revital-Ox PAA High Level Disinfectant Chemical Indicator is used for the routine monitoring of enspire 300 Series Automated Endoscope Reprocessor employing Revital-Ox PAA High Level Disinfectant. |
| 50724995217360 - Revital-Ox | 2023-09-08 The Revital-Ox PAA High Level Disinfectant Chemical Indicator is used for the routine monitoring of enspire 300 Series Automated |
| 10724995092945 - VERIFY | 2023-07-04 The VERIFY Chemical Indicator for S40 Sterilant is a peracetic acid concentration indicator for routine monitoring of the System |
| 50724995218589 - Celerity | 2022-08-18 Celerity HP Multivariable CI is designed for routine monitoring of Lumen, Non-Lumen, Flexible, Fast Non Lumen, Fast sterilizat |
| 10724995091108 - VERIFY | 2021-02-19 Vaporized VH202 Process Indicator |
| 50724995092943 - VERIFY | 2021-02-19 Chemical Indicator for SYSTEM 1E Processor |
| 10724995084629 - VERIFY | 2020-10-20 The VERIFY SixCess 250F 30 Minute Indicator Short are cycle verification indicators which are designed to react to all critical |
Trademark Results [Revital-Ox]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 REVITAL-OX 97113616 not registered Live/Pending |
STERIS Corporation 2021-11-08 |
 REVITAL-OX 85526241 4400911 Live/Registered |
STERIS CORPORATION 2012-01-26 |
 REVITAL-OX 85337306 4283577 Live/Registered |
STERIS CORPORATION 2011-06-03 |
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