Identity
- Trade Name
- Aroma Season FDA UDI
- Generic Name
- Electric pad localized-body heating system FDA UDI
- Device Name
- This is a device intended to placed over closed eyes to apply heat for the treatment of meibomian gland dysfunction, dry eye syndromes, blepharitis and other related ocular conditions FDA UDI
- Model / Reference
- M1200 FDA UDI
- Description
- This is a device intended to placed over closed eyes to apply heat for the treatment of meibomian gland dysfunction, dry eye syndromes, blepharitis and other related ocular conditions FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974736970002 FDA UDI
- FDA Product Code
- IRT FDA UDI
- GMDN Term
- Electric pad localized-body heating system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5740 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
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electric pad localized-body heating system
Aroma Season by Shanghai GK Industrial Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Shanghai GK Industrial Co., Ltd.
Sources (1)
- FDA UDI 0749c535-a13f-425c-a6bc-56405cdee5be 35 fields · synced Jun 1, 2026