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BiliSoft Phototherapy System

FDA UDI

Class II (US FDA UDI)

by Datex-Ohmeda Inc.

Identity

Trade Name
BiliSoft Phototherapy System FDA UDI
Generic Name
Overhead infant phototherapy unit FDA UDI
Model / Reference
BI2 FDA UDI

Identifiers

Primary DI / UDI-DI
00840682116534 FDA UDI
510(k) Number
K053568 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

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: Overhead infant phototherapy unit

BiliSoft Phototherapy System by Datex-Ohmeda Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Overhead infant phototherapy unit.

Cleared under the same submission

K053568 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Datex-Ohmeda Inc.

Sources (1)

  • FDA UDI 001184ce-dab7-4f43-8b11-b2022b612ea1 33 fields · synced Jun 1, 2026