FDA UDI
In Commercial Distribution
🇺🇸 United States
Dimension® Salt Bridge Solution
DI: 00842768004735
·
Model: 10444873
·
Siemens Healthcare Diagnostics Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
3
Basic Information
- Brand Name
- Dimension® Salt Bridge Solution
- Primary DI
- 00842768004735
- Version / Model
- 10444873
- Catalog Number
- D105
- Company Name
- Siemens Healthcare Diagnostics Inc.
- Labeler DUNS
- 005088112
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 3
- Record Status
- Published
- Publish Date
- 2020-09-24
- Public Version
- 2
- Public Version Date
- 2021-11-18
- Public Version Status
- Update
- Public Device Record Key
- b6146458-bff8-4b1e-82d8-7c1d1858f6a9
Device Description
Salt Bridge Solution, 3x150mL
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 |
|---|---|---|---|---|
| JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | Clinical Chemistry | 862.2160 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59238 | Ion selective electrode (ISE) reference solution IVD, reagent | A substance or reactant intended to be used together with a reference electrode to perform a specific function in an assay that is used for the quantitative measurement of one or multiple electrolytes in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842768004735 | GS1 | ||||
| Unit of Use | 00630414003788 | GS1 |
Customer Contacts
- Phone
- +1(800)441-9250
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius