Identity
- Trade Name
- Hang&Go HT Basic FDA UDI
- Generic Name
- Intravascular/intracavitary-circulation hyperthermia system set FDA UDI
- Device Name
- Kit for hyperthermic perfusion FDA UDI
- Model / Reference
- 002 FDA UDI
- Description
- Kit for hyperthermic perfusion FDA UDI
Identifiers
- Catalog Number
- R9900090 FDA UDI
- Primary DI / UDI-DI
- M640R99000900021 FDA UDI
- 510(k) Number
- K120026 FDA UDI
- FDA Product Code
- LGZ FDA UDI
- GMDN Term
- Intravascular/intracavitary-circulation hyperthermia system set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5725 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Intravascular/intracavitary-circulation hyperthermia system set
Hang&Go HT Basic by Rand Spa — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Intravascular/intracavitary-circulation hyperthermia system set.
Cleared under the same submission
K120026 also covers:
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
- Rand Spa
Sources (2)
- FDA UDI da973ef1-4a20-4c8c-bdb6-b116eb678f35 36 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026