Chemdye®
GUDID 07798375770224
Bowie-Dick Test Sheet
TERRAGENE S.A.
Chemical/physical sterilization process indicator| Primary Device ID | 07798375770224 |
| NIH Device Record Key | 2fb1d31a-3a14-41dd-a19e-c4103ea6be06 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Chemdye® |
| Version Model Number | BDA4/1 |
| Company DUNS | 970856911 |
| Company Name | TERRAGENE S.A. |
| 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 | 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 | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07798164677857 [Primary] |
| GS1 | 07798375770224 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K200272
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 | 2022-03-29 |
| Device Publish Date | 2022-03-21 |
On-Brand Devices [Chemdye® ]
| 07798164676850 | Chemical Indicator strip for monitoring hydrogen peroxide sterilization processes. |
| 07798164676843 | Chemical indicator strip for monitoring hydrogen peroxide sterilization processes. |
| 07798164678847 | Chemical indicator Bowie-Dick Test Pack with Warning Sheet. |
| 07798164679295 | Bowie-Dick Test Cards with holder |
| 07798164677871 | Bowie-Dick Test Card |
| 07798375770224 | Bowie-Dick Test Sheet |
| 07798164676805 | Multivariable process indicator for monitoring Ethylene Oxide sterilization processes |
| 07798164676836 | Multivariable process indicator for monitoring Steam sterilization processes |
Trademark Results [Chemdye]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CHEMDYE 88059790 5697020 Live/Registered |
Terragene S.A. 2018-07-31 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.