Identity
- Trade Name
- Varian IDENTIFY FDA UDI
- Generic Name
- Real-time position management respiratory gating system, optical FDA UDI
- Model / Reference
- 2.2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00899475002592 FDA UDI
- 510(k) Number
- K192968 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Real-time position management respiratory gating system, optical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5050 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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Real-time position management respiratory gating system, optical
Varian IDENTIFY by Varian Medical Systems, Inc — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Real-time position management respiratory gating system, optical.
- Respiratory Gating for Scanners (RGSC) — Varian Medical Systems Imaging Laboratory GmbH · Class II
- Identify — Varian Medical Systems, Inc · Class II
- Varian RPM Gating Marker Block (6 Dot) — Varian Medical Systems, Inc · Class II
- Beacon Care Package - Surface — Varian Medical Systems, Inc · Class II
- RPM Respiratory Gating System — Varian Medical Systems, Inc · Class II
- Varian RPM Gating Marker Block (2 Dot) — Varian Medical Systems, Inc · Class II
- Varian RPM Respiratory Gating System — Varian Medical Systems, Inc · Class II
- RPM Respiratory Gating System — Varian Medical Systems, Inc · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Varian Medical Systems, Inc
Sources (2)
- FDA UDI 5f9f0869-7d69-48d9-b922-eda4530775ce 33 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026