Who else makes this device?

Name: Ultra Bili Light
Brand: Ultra Bili Light

General Hospital › TherapeuticUnit, Neonatal Phototherapy

Ultra Bili Light

Catalogue number 2000, listed by Physician Engineered Products, Inc., United States, under Unit, Neonatal Phototherapy. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

1catalogue number

6510(k) clearances naming this product code

1recall

Who Else Makes It

Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code LBI
Manufacturer	City	Province	Registered as	Device types
Amphenol (Changzhou) Connector Systems Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	4

Record

Regulatory record for Ultra Bili Light
Listed by	Physician Engineered Products, Inc., United States
FDA product code	LBI
Device type	Unit, Neonatal Phototherapy
Device class	Class 2
Regulation	21 CFR 880.5700
510(k)	K974830
Record published	2017-08-03
Record revised	2018-07-06 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	serial number

Catalogue Numbers

Catalogue numbers for Ultra Bili Light
Catalogue number	Size	Status
2000		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
bili-hut™	Little Sparrows Technologies Inc	33
NeoBLUE blanket LED Phototherapy	Natus Medical Denmark ApS	10
neoBLUE	Natus Medical Incorporated	9
Bilisoft 2.0	Lumitex, Inc.	4
BiliSoft Phototherapy System	Datex-Ohmeda, Inc.	3
Lamp	RPI	3
Giraffe Blue Spot PT Lite	Datex-Ohmeda, Inc.	2
BiliCocoon™ Nest System	Neomedlight	2
BiliCocoon™ Bag System	Neomedlight	2
BiliCocoon™ Nest Disposable	Neomedlight	2
Unit, Neonatal Phototherapy	Bistos Co., Ltd.	2
BiliCocoon™ Bag Pad	Neomedlight	2

Showing 12 of 61. All products under Unit, Neonatal Phototherapy

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K110550	2012-02-03
K093618	2010-04-23
K974830	1998-05-20
K882291	1988-06-20
K873700	1987-12-11
K850599	1985-06-17

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2013-08-31	Class II	Device Design	Upper limit for ambient temperature for use of the device was printed incorrectly in the instructions	97 units	2015-09-02

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.