FDA UDI
In Commercial Distribution
🇺🇸 United States
ProChem SSW
DI: M985CISSW1
·
Model: Class 5 Integrator
·
MESA LABORATORIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
250
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Basic Information
- Brand Name
- ProChem SSW
- Primary DI
- M985CISSW1
- Version / Model
- Class 5 Integrator
- Catalog Number
- CI-SSW
- Company Name
- MESA LABORATORIES, INC.
- Labeler DUNS
- 102530326
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 250
- Record Status
- Published
- Publish Date
- 2018-04-02
- Public Version
- 1
- Public Version Date
- 2018-05-03
- Public Version Status
- New
- Public Device Record Key
- 2672bc74-07a3-4f26-984a-f3a8ea611955
Device Description
ProChem SSW Steam Sterilization Integrator for use in steam sterilizers only. Contains 250 units (1 bag of 250 each).
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 |
|---|---|---|---|---|
| JOJ | Indicator, Physical/Chemical 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 | M985CISSW250 | HIBCC | 250 | In Commercial Distribution | ||
| Primary | M985CISSW1 | HIBCC | ||||
| Unit of Use | M985CISSW0 | HIBCC |