Identity
- Trade Name
- VENTANA HE 600 Cleaning Solution FDA UDI
- Generic Name
- Wash/cleaning solution IVD, automated/semi-automated system FDA UDI
- Model / Reference
- 07257538001 FDA UDI
Identifiers
- Catalog Number
- 07257538001 FDA UDI
- Primary DI / UDI-DI
- 04015630974801 FDA UDI
- FDA Product Code
- PPM FDA UDI
- GMDN Term
- Wash/cleaning solution IVD, automated/semi-automated system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4010 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Wash/cleaning solution IVD, automated/semi-automated system
VENTANA HE 600 Cleaning Solution by Ventana Medical Systems — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wash/cleaning solution IVD, automated/semi-automated system.
- PHOENIX DIAGNOSTICS, INC. — PHOENIX DIAGNOSTICS, INC. · Class I
- DAB Away — BIOCARE MEDICAL, LLC · Class I
- ACE — Alfa Wassermann, Inc.
- ADVIA 120/212-/2120i Perox Flow Cell Wash Kit — Siemens Healthcare Diagnostics · Class I
- ADVIA® 360/560 Hypoclean 100 mL — Siemens Healthcare Diagnostics · Class II
- Capillary Adapter Cleaning Kit — Medica Corp. · Class II
- Dimension® Reagent Probe Cleaner — Siemens Healthcare Diagnostics · Class I
- ADVIA Centaur® Cleaning Solution Concentrate — Siemens Healthcare Diagnostics · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ventana Medical Systems
Sources (1)
- FDA UDI 97524e10-4704-4c78-9e43-406ae723d8c5 33 fields · synced May 30, 2026