FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Smart-Read EZTest Biological Test Pack
DI: M985SRSP050
·
Model: 10e5/5 controls
·
MESA LABORATORIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Smart-Read EZTest Biological Test Pack
- Primary DI
- M985SRSP050
- Version / Model
- 10e5/5 controls
- Catalog Number
- SRSP/05
- Company Name
- MESA LABORATORIES, INC.
- Labeler DUNS
- 102530326
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-30
- Public Version
- 3
- Public Version Date
- 2018-12-04
- Public Version Status
- Update
- Public Device Record Key
- 5f4ca1d0-834c-4386-b1cb-3f581d8b447b
- Distribution End Date
- 2018-01-06
Device Description
Mesa Labs Smart-Read EZTest Biological Test Pack with Instant Readout Integrator
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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 |
|---|---|---|---|---|---|---|
| Package | M985SRSP051 | HIBCC | case | 25 | Not in Commercial Distribution | 2018-01-06 |
| Primary | M985SRSP050 | HIBCC |