FDA UDI
In Commercial Distribution
🇺🇸 United States
Oivi Opthalmic Fundus Camera
DI: 00860010826812
·
Model: OFC100L
·
Oivi AS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Oivi Opthalmic Fundus Camera
- Primary DI
- 00860010826812
- Version / Model
- OFC100L
- Company Name
- Oivi AS
- Labeler DUNS
- 346420577
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-01-15
- Public Version
- 2
- Public Version Date
- 2024-01-25
- Public Version Status
- Update
- Public Device Record Key
- 076db03f-587f-47ba-ae04-b057281503d6
Device Description
The OFC100L is a high-resolution ophthalmic imaging device that is primarily intended for photographing the fundus of the eye with / without dilating the pupil. It is a prescription-use medical device only.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| PJZ | Camera, Ophthalmic, General-Use | Ophthalmic | 886.1120 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10551 | Ophthalmic fundus camera | An electrically-powered optical device intended to be used to create digital colour photographic images/video of the ocular fundus (interior eye surface opposite the lens) through the pupil, to aid in diagnosing and monitoring retinal pathology; it may also be used for images/video of the anterior chamber. The image/video is typically transferred to a computer for display on its screen and/or for storage in a database. This device is also known as a retinal camera. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860010826812 | GS1 |
Customer Contacts
- Phone
- 1-800-917-6971
- [email protected]
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 50 Degrees Celsius