FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Revital-Ox Resert
DI: 10724995002210
·
Model: PCC053
·
ALBERT BROWNE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
60
Basic Information
- Brand Name
- Revital-Ox Resert
- Primary DI
- 10724995002210
- Version / Model
- PCC053
- Catalog Number
- PCC053
- Company Name
- ALBERT BROWNE LIMITED
- Labeler DUNS
- 218172765
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 60
- Record Status
- Published
- Publish Date
- 2016-09-06
- Public Version
- 5
- Public Version Date
- 2020-05-22
- Public Version Status
- Update
- Public Device Record Key
- 5829b648-18e5-4145-8960-1e2b9c2ea4cf
- Distribution End Date
- 2020-05-22
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 |
|---|---|---|---|---|---|---|
| Primary | 10724995002210 | GS1 | ||||
| Unit of Use | 00724995002213 | GS1 |
Customer Contacts
- Phone
- +1(800)548-4873
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry and Keep away from direct light
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 80 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 43 – 86 Degrees Fahrenheit