FDA UDI
In Commercial Distribution
🇺🇸 United States
Icare ic200
DI: 06430033851036
·
Model: TA031
·
ICARE FINLAND OY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Icare ic200
- Primary DI
- 06430033851036
- Version / Model
- TA031
- Company Name
- ICARE FINLAND OY
- Labeler DUNS
- 651755092
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-01-17
- Public Version
- 1
- Public Version Date
- 2020-01-27
- Public Version Status
- New
- Public Device Record Key
- 385b0c2f-6aef-4469-9264-e6d57d5075ac
Device Description
The Icare ic200 (TA031) tonometer is a hand-held, battery operated device, which measures intraocular pressure (IOP) without the need for topical anesthesia. The Icare ic200 tonometer measures the IOP by utilizing the rebound method. The Icare ic200 tonometer is intended to be used for the measurement of intraocular pressure of the human eye. Icare ic200 allows IOP measurement of patients in all positions between sitting and supine positions. IOP measurement result can be transferred to printer or to a PC via Bluetooth connection.
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
- Yes
- 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 |
|---|---|---|---|---|
| HKY | Tonometer, Manual | Ophthalmic | 886.1930 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16809 | Ophthalmic tonometer, battery-operated | An ophthalmic, battery-powered, measuring instrument designed for determining the intraocular pressure (IOP) by exerting an external force against the eye which provides a reading of the resistance of the tunica of the eye to deformation (the extent of corneal indentation) which is expressed in millimetre(s) of mercury (mmHg). This hand-held device (known as a contact type, e.g., a Perkins tonometer) is often used for, e.g., the examination of postoperative, bedridden and paediatric patients. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06430033851036 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K190316 | 000 |