Identity
- Trade Name
- DAAVLIN FDA UDI
- Generic Name
- Ultraviolet phototherapy unit, professional FDA UDI
- Device Name
- 7 Ser T 311-8 220-240V 50Hz FDA UDI
- Model / Reference
- 7 Series FDA UDI
- Description
- 7 Ser T 311-8 220-240V 50Hz FDA UDI
Identifiers
- Primary DI / UDI-DI
- B2809808HO0008T5 FDA UDI
- 510(k) Number
- K050695 FDA UDI
- FDA Product Code
- FTC FDA UDI
- GMDN Term
- Ultraviolet phototherapy unit, professional FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4630 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
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
No
FDA UDI
Category: Ultraviolet phototherapy unit, professional
Daavlin by Daavlin Distributing Co., The — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ultraviolet phototherapy unit, professional.
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- Solarc/SolRx 1000-Series — Solarc Systems Inc · Class II
- Full Body Unit, 48 UVA/UVB Combination Unit — ULTRALITE ENTERPRISES INC · Class II
- National Biological Corporation — National Biological Corp. · Class II
- Solarc/SolRx E-Series — Solarc Systems Inc · Class II
- UVBioTek — Medtek Lighting Corp · Class II
- National Biological Corporation — National Biological Corp. · Class II
- Full Body Unit, 48 Lamp UVA Unit — ULTRALITE ENTERPRISES INC · Class II
Cleared under the same submission
K050695 also covers:
- DAAVLIN — DAAVLIN DISTRIBUTING CO., THE
- DAAVLIN — DAAVLIN DISTRIBUTING CO., THE
- DAAVLIN — DAAVLIN DISTRIBUTING CO., THE
- DAAVLIN — DAAVLIN DISTRIBUTING CO., THE
- DAAVLIN — DAAVLIN DISTRIBUTING CO., THE
- DAAVLIN — DAAVLIN DISTRIBUTING CO., THE
- DAAVLIN — DAAVLIN DISTRIBUTING CO., THE
- DAAVLIN — DAAVLIN DISTRIBUTING CO., THE
- DAAVLIN — DAAVLIN DISTRIBUTING CO., THE
- DAAVLIN — DAAVLIN DISTRIBUTING CO., THE
- DAAVLIN — DAAVLIN DISTRIBUTING CO., THE
- DAAVLIN — DAAVLIN DISTRIBUTING CO., THE
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
- Daavlin Distributing Co., The
Sources (1)
- FDA UDI c91a4e37-220f-45f1-8a5e-50f898083e96 35 fields · synced Jun 7, 2026