FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Attest™
DI: 30605861032415
·
Model: 1261P
·
3M COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
25
Basic Information
- Brand Name
- Attest™
- Primary DI
- 30605861032415
- Version / Model
- 1261P
- Catalog Number
- 1261P
- Company Name
- 3M COMPANY
- Labeler DUNS
- 830016148
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2023-04-27
- Public Version Status
- Update
- Public Device Record Key
- 53996476-1a62-4192-a2e9-964ceda43819
- Distribution End Date
- 2023-04-27
Device Description
3M™ ESPE™ Attest™ Biological Indicators for 270°F/132°C Gravity Displacement Steam Sterilizers, 1261P
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
- Yes
- 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 |
|---|---|---|---|---|---|---|
| Package | 50605861032419 | GS1 | BOX | 4 | Not in Commercial Distribution | 2023-04-27 |
| Primary | 30605861032415 | GS1 | ||||
| Unit of Use | 00605861032414 | GS1 |
Customer Contacts
- Phone
- +1(800)634-2249
- [email protected]