Who else makes this device?

Name: modification kit phototherapy
Brand: modification kit phototherapy

General Hospital › TherapeuticUnit, Neonatal Phototherapy

Modification Kit Phototherapy

Catalogue number 2M30450, listed by Drägerwerk AG & Co. KGaA, Germany, under Unit, Neonatal Phototherapy. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

1catalogue number

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 modification kit phototherapy
Listed by	Drägerwerk AG & Co. KGaA, Germany
FDA product code	LBI
Device type	Unit, Neonatal Phototherapy
Device class	Class 2
Regulation	21 CFR 880.5700
510(k)	K954611
Record published	2015-10-24
Record revised	2026-01-12 (version 4)

Specifications

Specifications
MRI safety	MR Unsafe
Label carries	manufacturing date, serial number
Distribution end date	2026-01-09

Catalogue Numbers

Catalogue numbers for modification kit phototherapy
Catalogue number	Size	Status
2M30450		Withdrawn

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

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of modification kit phototherapy
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Draeger Medical Systems, Inc.	510(k) number	2012-07-02	Class II	Other	A routine internal quality check found that the Drager PT 4000 Phototherapy System is fitted with a 16 Amp rated fuse instead of the specified 1.6 Amp rated fuse. This may mean that the internal fuse would not trip promptly in the event of	65	2013-07-01

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.