FDA UDI
In Commercial Distribution
🇺🇸 United States
VERIFY
DI: 10724995096240
·
Model: LCB001
·
STERIS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
Basic Information
- Brand Name
- VERIFY
- Primary DI
- 10724995096240
- Version / Model
- LCB001
- Catalog Number
- LCB001
- Company Name
- STERIS CORPORATION
- Labeler DUNS
- 961394798
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2016-09-09
- Public Version
- 5
- Public Version Date
- 2020-11-03
- Public Version Status
- Update
- Public Device Record Key
- d4a0461d-b28f-4c4a-bf5c-a5526ca686ee
Device Description
The VERIFY Spore Test Strip for S40 Sterilant offers the ability to test sporicidal activity of the S40 use dilution within the liquid chemical sterilization cycle.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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 |
|---|---|---|---|---|
| OVY | Liquid chemical processing system | General Hospital | 880.6887 | 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 | 10724995096240 | GS1 | ||||
| Unit of Use | 00724995096243 | GS1 |
Customer Contacts
- Phone
- +1(800)548-4873
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store away from heat
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 80 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 36 – 75 Degrees Fahrenheit