FDA UDI
In Commercial Distribution
🇺🇸 United States
Miris Cleaner™
DI: 07350107530034
·
Model: 39-04-001
·
Miris AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Miris Cleaner™
- Primary DI
- 07350107530034
- Version / Model
- 39-04-001
- Catalog Number
- 39-04-001
- Company Name
- Miris AB
- Labeler DUNS
- 632704677
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-04-23
- Public Version
- 5
- Public Version Date
- 2023-10-18
- Public Version Status
- Update
- Public Device Record Key
- 02a8a3cc-e121-4a98-8995-439e46cd51ef
Device Description
Cleaning solution for Miris Human Milk Analyzer™. Concentrate, 50 mL. Dilute the content with 950 mL distilled or deionized water and mix. Warm to 35-40°C before use.
Device Characteristics
- Single Use
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| QEI | Breast Milk Macronutrients Test System | Clinical Chemistry | 862.1493 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59059 | Wash/cleaning solution IVD, manual equipment | A wash or cleaning solution intended to be used in the preparation, decontamination and/or cleanup of equipment (e.g., glassware, weighing equipment) used for the manual processing, staining and/or testing of clinical laboratory specimens. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07350107530034 | GS1 |
Customer Contacts
- Phone
- +4618146907
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN180007 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 50 | Milliliter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- out of direct sunlight
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 30 Degrees Celsius