FDA UDI
In Commercial Distribution
🇺🇸 United States
TDS Standard Solution
DI: M985020077
·
Model: 02.0077
·
MESA LABORATORIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- TDS Standard Solution
- Primary DI
- M985020077
- Version / Model
- 02.0077
- Catalog Number
- 02.0077
- Company Name
- MESA LABORATORIES, INC.
- Labeler DUNS
- 102530326
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-04
- Public Version
- 1
- Public Version Date
- 2020-05-12
- Public Version Status
- New
- Public Device Record Key
- a91e9d34-31cf-4b30-9f8b-c6c517a796a1
Device Description
Total Dissolved Solids Solution 150ppm 229uS/cm 1Pt
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| FKH | Solution-Test Standard-Conductivity, Dialysis | Gastroenterology, Urology | 876.5820 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47678 | Haemodialysis conductivity standard solution | A salt solution, typically salt dissolved in deionized/purified water, used to calibrate conductivity meters used to test the conductivity of dialysate, dialysate concentrate, and water treatment systems used with haemodialysis delivery systems. The solution is typically available in sealed plastic bottles and in a range of values and accuracies. It may be available over-the-counter. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | M985020583 | HIBCC | Carton | 12 | In Commercial Distribution | |
| Primary | M985020077 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191496 | 000 |