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Model 30™ Tip and Membrane Assembly for Pneumatonometer
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Model 30™ Tip and Membrane Assembly for Pneumatonometer FDA UDI
- Generic Name
- Ophthalmic tonometer, line-powered FDA UDI
- Device Name
- Ten (10) replacement tip and membrane assemblies that attach to the Model 30 Pneumatonometer probe. Probe tip touches a patient's cornea during the measurement. FDA UDI
- Model / Reference
- 230678 FDA UDI
- Description
- Ten (10) replacement tip and membrane assemblies that attach to the Model 30 Pneumatonometer probe. Probe tip touches a patient's cornea during the measurement. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812559012188 FDA UDI
- FDA Product Code
- HKX FDA UDI
- GMDN Term
- Ophthalmic tonometer, line-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.1930 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ophthalmic tonometer, line-powered
Model 30™ Tip and Membrane Assembly for Pneumatonometer by Reichert Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic tonometer, line-powered.
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- AUTO REF/KERATO/TONOMETER — Nidek, Inc. · Class II
- Falck Medical Multi-Function Applanation Tonometer — Falck Medical, Inc. · Class II
- NON-CONTACT TONOMETER — Tomey Corporation · Class II
- Eli Ezer — U.S. OPHTHALMIC, L.L.C. · Class II
- WAVE ANALYZER MEDICA 800 — ESSILOR INTERNATIONAL · Class II
- NON-CONTACT TONOMETER — Tomey Corporation · Class II
- NON-CONTACT TONOMETER — Tomey Corporation · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Reichert Inc.
Sources (1)
- FDA UDI 528eec58-5a74-4a23-b2c9-24212c87f53c 34 fields · synced Jun 8, 2026