FDA UDI
In Commercial Distribution
🇺🇸 United States
VERIFY
DI: 10724995220324
·
Model: LCB006
·
STERIS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
20
Basic Information
- Brand Name
- VERIFY
- Primary DI
- 10724995220324
- Version / Model
- LCB006
- Catalog Number
- LCB006
- Company Name
- STERIS CORPORATION
- Labeler DUNS
- 961394798
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2023-04-20
- Public Version
- 1
- Public Version Date
- 2023-04-28
- Public Version Status
- New
- Public Device Record Key
- 6624b2f0-58d8-4c09-a55d-f508daf3ce7f
Device Description
The VERIFY Biological Integrator Challenge Packs are used to release dynamic air removal (prevacuum and steam-flush pressure-pulse) and steam sterilization (autoclave) cycles.
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 |
|---|---|---|---|---|
| FRC | Indicator, biological sterilization process | General Hospital | 880.2800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13732 | Biological sterilization indicator | A sterilization indicator consisting of a standardized, viable population of microorganisms (e.g., bacterial spores known to be resistant to the mode of sterilization being monitored) that will display a change when exposed to an effective sterilization outcome indicating that sterilization parameters have been met. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00724995220327 | GS1 | ||||
| Primary | 10724995220324 | GS1 | ||||
| Previous | 10724995084667 | GS1 |
Customer Contacts
- Phone
- +1(800)548-4873
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K854902 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do Not Freeze
- Type
- Storage Environment Humidity
- Temperature Range
- 35 – 60 Percent (%) Relative Humidity
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from direct light
- Type
- Storage Environment Temperature
- Temperature Range
- 59 – 77 Degrees Fahrenheit