FDA UDI
In Commercial Distribution
🇺🇸 United States
VERIFY
DI: 10724995172197
·
Model: PCC029
·
ALBERT BROWNE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
60
Basic Information
- Brand Name
- VERIFY
- Primary DI
- 10724995172197
- Version / Model
- PCC029
- Catalog Number
- PCC029
- 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
- 4
- Public Version Date
- 2021-02-19
- Public Version Status
- Update
- Public Device Record Key
- 4f734884-0597-4272-99e1-54a053f7145c
Device Description
The VERIFY Process Indicator for the Reliance EPS Endoscope Processing System is a peracetic acid concentration indicator that changes color to the ENDPOINT reference block upon exposure to an effective dose of peracetic acid. It is intended for use for routine monitoring of the Reliance EPS Endoscope Processing System employing Reliance DG Dry Germicide.
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 |
|---|---|---|---|---|
| 35362 | Chemical/physical sterilization process indicator | A sterilization indicator designed to be placed within a sterilizing chamber, and to respond with a characteristic chemical and/or physical change to one or more of the physical conditions within the chamber, to validate the sterilization process. It may be presented in one of a variety of forms (e.g., tape, test pack, tag). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50724995172195 | GS1 | Box | 2 | In Commercial Distribution | |
| Primary | 10724995172197 | GS1 | ||||
| Unit of Use | 00724995172190 | GS1 | ||||
| Previous | 10724995087941 | GS1 |
Customer Contacts
- Phone
- +1(800)548-4873
- [email protected]