FDA UDI
In Commercial Distribution
🇺🇸 United States
Revital-Ox Resert
DI: 10724995172210
·
Model: PCC054
·
ALBERT BROWNE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
60
Basic Information
- Brand Name
- Revital-Ox Resert
- Primary DI
- 10724995172210
- Version / Model
- PCC054
- Catalog Number
- PCC054
- Company Name
- ALBERT BROWNE LIMITED
- Labeler DUNS
- 218172765
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 60
- Record Status
- Published
- Publish Date
- 2020-05-29
- Public Version
- 3
- Public Version Date
- 2020-10-28
- Public Version Status
- Update
- Public Device Record Key
- 43dd3065-7838-412f-a8c7-d9668eeb8279
Device Description
The Revital-Ox Resert R60 Solution Test Strip is a chemical indicator designed exclusively for monitoring of Revital-Ox RESERT High Level Solutions.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JOJ | Indicator, physical/chemical sterilization process | General Hospital | 880.2800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58056 | Peracetic acid device disinfectant/sterilant test strip | A sliver of absorbent material impregnated with chemical indicators and dyes intended to be used to rapidly indicate, through colour change, the concentration of peracetic acid in a device disinfectant and/or sterilant solution after preparation to ensure disinfectant/sterilant properties. It is used to prevent diluting the disinfectant/sterilant to a concentration that is lower than the manufacturer's recommended minimum effective concentration (MEC). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50724995172218 | GS1 | Box | 2 | In Commercial Distribution | |
| Primary | 10724995172210 | GS1 | ||||
| Unit of Use | 00724995172213 | GS1 | ||||
| Previous | 10724995002227 | GS1 |
Customer Contacts
- Phone
- +1(800)548-4873
- [email protected]