FDA UDI
Not in Commercial Distribution
🇺🇸 United States
VERIFY
DI: 10724995023871
·
Model: S3070
·
STERIS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
Basic Information
- Brand Name
- VERIFY
- Primary DI
- 10724995023871
- Version / Model
- S3070
- Catalog Number
- S3070
- Company Name
- STERIS CORPORATION
- Labeler DUNS
- 961394798
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2016-09-09
- Public Version
- 6
- Public Version Date
- 2020-10-19
- Public Version Status
- Update
- Public Device Record Key
- 464f6ceb-53ad-4f54-93c3-39965f7e8f8b
- Distribution End Date
- 2020-10-19
Device Description
The VERIFY Disposable Biological EO Test Packs are for use in monitoring healthcare ethylene oxide (EO) sterilization processes. Each test pack contains 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 |
|---|---|---|---|---|---|---|
| Primary | 10724995023871 | GS1 | ||||
| Unit of Use | 00724995023874 | GS1 |
Customer Contacts
- Phone
- +1(800)548-4873
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K854631 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not Freeze
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from Heat