FDA UDI
In Commercial Distribution
🇺🇸 United States
TearLab Osmolarity Test Card
DI: 00853539002034
·
Model: 100003
·
Tearlab Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100000
Basic Information
- Brand Name
- TearLab Osmolarity Test Card
- Primary DI
- 00853539002034
- Version / Model
- 100003
- Company Name
- Tearlab Corporation
- Labeler DUNS
- 155813749
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100000
- Record Status
- Published
- Publish Date
- 2025-08-28
- Public Version
- 1
- Public Version Date
- 2025-09-05
- Public Version Status
- New
- Public Device Record Key
- cbcaa2ce-bbb0-4786-9576-c58a41e1d218
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 |
|---|---|---|---|---|
| OND | Osmolality Of Tears | Clinical Chemistry | 862.1540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52887 | Osmolality IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of osmolality of a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00853539002034 | GS1 | ||||
| Unit of Use | 10853539002031 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K083184 | 000 |