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Ultra Bili Light

FDA UDI

Class II (US FDA UDI)

by Physician Engineered Products, Inc.

Identity

Trade Name
Ultra Bili Light FDA UDI
Generic Name
Overhead infant phototherapy unit FDA UDI
Model / Reference
2000 FDA UDI

Identifiers

Catalog Number
UBL5000 FDA UDI
Primary DI / UDI-DI
00183415000107 FDA UDI
510(k) Number
K974830 FDA UDI
FDA Product Code
LBI FDA UDI
GMDN Term
Overhead infant phototherapy unit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5700 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

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: Overhead infant phototherapy unit

Ultra Bili Light by Physician Engineered Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Overhead infant phototherapy unit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Physician Engineered Products, Inc.

Sources (1)

  • FDA UDI 0cf7d4e1-6119-421a-9639-5d9a2c46b6ea 35 fields · synced May 30, 2026