FDA UDI
In Commercial Distribution
🇺🇸 United States
KOWA FM-600
DI: 04987646804024
·
Model: LSS50BK
·
KOWA COMPANY,LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- KOWA FM-600
- Primary DI
- 04987646804024
- Version / Model
- LSS50BK
- Company Name
- KOWA COMPANY,LTD.
- Labeler DUNS
- 692281073
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-16
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- cb1ee304-13ff-4c43-9105-03c9ade03685
Device Description
KOWA FM-600 is an instrument to measure the protein level contained in aqueous humor of the anterior chamber of human eye.
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MYC | Ophthalmoscope,Laser,Scanning | Ophthalmic | 886.1570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37948 | Aqueous flare/cell measuring system | An assembly of devices designed to measure aqueous flare (i.e., protein concentration) and the number of cells in the aqueous humour. It typically consists of light sources (e.g., lasers), a slit-lamp microscope, photo-multipliers, and dedicated software. The system measures the light scattered from the protein and cells in the aqueous humour using a photo-multiplier and analyse the results typically using a personal computer; it is mainly used to assess anterior chamber inflammation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04987646804024 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K091039 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 458 | Millimeter | |
| Depth | 457 | Millimeter | |
| Width | 274 | Millimeter | |
| Weight | 18 | Kilogram |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -15 – 50 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 60 Percent (%) Relative Humidity