FDA UDI
In Commercial Distribution
🇺🇸 United States
Model 30 Pneumatonometer
DI: 00812559010979
·
Model: 16032
·
REICHERT, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Model 30 Pneumatonometer
- Primary DI
- 00812559010979
- Version / Model
- 16032
- Company Name
- REICHERT, INC.
- Labeler DUNS
- 126650253
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- aa4be1df-877e-498e-a66b-1b2424938ba5
Device Description
AC powered contact tonometer intended for the measurement of intraocular pressure (IOP). The device is indicated for use as a screening /monitoring tool for glaucoma or when increased IOP is suspected.
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
- Yes
- 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 |
|---|---|---|---|---|
| HKX | Tonometer, Ac-Powered | Ophthalmic | 886.1930 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35399 | Ophthalmic tonometer, line-powered | An ophthalmic, line-powered, measuring instrument used 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). It typically has no contact with the eye and can use various techniques, e.g., the air-puff tonometer records deflections of the cornea from a puff of pressurized air; the applanation tonometer records the indentation pressure in thousands of a second. It is used for the diagnosis of glaucoma, designed for table top use and may provide the data on a screen and/or a print-out. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00812559010979 | GS1 |
Customer Contacts
- Phone
- 1-888-849-8955
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K002395 | 000 |