Identity
- Trade Name
- TruLight FDA UDI
- Generic Name
- Operating room light FDA UDI
- Device Name
- Hillrom™ TruLight 5000/ 3000 Ceiling Trio FDA UDI
- Model / Reference
- 4038310 FDA UDI
- Description
- Hillrom™ TruLight 5000/ 3000 Ceiling Trio FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00887761995901 FDA UDI
- FDA Product Code
- FQP FDA UDIFTD FDA UDIFSY FDA UDIFSQ FDA UDI
- GMDN Term
- Operating room light FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4580 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
TruLight by Baxter Medical Systems GmbH + Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Baxter Medical Systems GmbH + Co. KG
Sources (1)
- FDA UDI 2f61e23f-22c3-4a41-9ef6-e63e0b722fa6 35 fields · synced May 30, 2026