FDA UDI
In Commercial Distribution
🇺🇸 United States
VERIFY
DI: 10724995220300
·
Model: S3065
·
STERIS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
20
Basic Information
- Brand Name
- VERIFY
- Primary DI
- 10724995220300
- Version / Model
- S3065
- Catalog Number
- S3065
- 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
- 2089aed7-8ad9-4795-95c8-8640ef506981
Device Description
The VERIFY Disposable Biological Steam Test Pack is a single use test pack designed for monitoring the effectiveness of common steam sterilizing processes, including 250 degrees F (121 degrees C) gravity cycles and 270 degrees F (132 C) prevacuum cycles. 20 Packs with 5 Controls.
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 | 00724995220303 | GS1 | ||||
| Primary | 10724995220300 | GS1 | ||||
| Previous | 10724995023840 | 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
- Special Storage Condition, Specify
- Special Conditions
- Keep from Heat
- Type
- Storage Environment Temperature
- Temperature Range
- 68 – 77 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 60 Percent (%) Relative Humidity