FDA UDI
In Commercial Distribution
🇺🇸 United States
NeurOptics
DI: 00850010118079
·
Model: NPi-200 System
·
Neuroptics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NeurOptics
- Primary DI
- 00850010118079
- Version / Model
- NPi-200 System
- Catalog Number
- NPi-200 Kit
- Company Name
- Neuroptics, Inc.
- Labeler DUNS
- 966355802
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-10-27
- Public Version
- 1
- Public Version Date
- 2020-11-04
- Public Version Status
- New
- Public Device Record Key
- 04422430-ff90-451f-9fe1-f73f7f4dc67d
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| HLG | Pupillometer, Ac-Powered | Ophthalmic | 886.1700 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13235 | Pupillograph | A mains electricity (AC-powered) graphic recorder used for recording the response of the pupil to reflected light. It is used for ophthalmic diagnostic purposes. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850010118079 | GS1 |
Customer Contacts
- Phone
- 949-250-9792
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 75 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity