Identity
- Trade Name
- Compumedics FDA UDI
- Generic Name
- Polysomnograph FDA UDI
- Device Name
- Grael event button V2_Green FDA UDI
- Model / Reference
- 7028-0006-02 FDA UDI
- Description
- Grael event button V2_Green FDA UDI
Identifiers
- Catalog Number
- 7028-0006-02 FDA UDI
- Primary DI / UDI-DI
- 09342451001849 FDA UDI
- 510(k) Number
- K093223 FDA UDI
- FDA Product Code
- GWQ FDA UDI
- GMDN Term
- Polysomnograph FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1400 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
Yes
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: Polysomnograph
Compumedics by Compumedics Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K093223 also covers:
- Compumedics — COMPUMEDICS LIMITED
- Compumedics — COMPUMEDICS LIMITED
- Compumedics Grael — COMPUMEDICS LIMITED
- Compumedics Grael — COMPUMEDICS LIMITED
- Compumedics Grael — COMPUMEDICS LIMITED
- Compumedics Grael — COMPUMEDICS LIMITED
- Compumedics Grael — COMPUMEDICS LIMITED
- Compumedics Grael — COMPUMEDICS LIMITED
- Compumedics Grael — COMPUMEDICS LIMITED
- Compumedics Grael — COMPUMEDICS LIMITED
- Compumedics Grael — COMPUMEDICS LIMITED
- Compumedics Grael — COMPUMEDICS LIMITED
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Compumedics Limited
Sources (1)
- FDA UDI 0c5ae9d5-41d5-4471-93fc-c88f052c9e67 36 fields · synced May 30, 2026