Who else makes this device?

Name: Bili-Therapy Pad Type
Brand: Bili-Therapy Pad Type

General Hospital › TherapeuticUnit, Neonatal Phototherapy

Bili-Therapy Pad Type

Catalogue number 60370, listed by Atom Medical Corporation, Japan, under Unit, Neonatal Phototherapy. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

1catalogue number

2510(k) clearances naming this product code

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 Bili-Therapy Pad Type
Listed by	Atom Medical Corporation, Japan
FDA product code	LBI
Device type	Unit, Neonatal Phototherapy
Device class	Class 2
Regulation	21 CFR 880.5700
Establishment	Contract manufacturer, Manufacturer, Exporter
Record published	2016-09-21
Record revised	2024-02-16 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	manufacturing date, serial number
Storage	Handling environment temperature 10 to 30 °C
Sizes	Depth 220 mm; width 150 mm

Catalogue Numbers

Catalogue numbers for Bili-Therapy Pad Type
Catalogue number	Size	Status
60370	Depth 220 mm	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
K111547	2012-04-12
K103828	2011-03-29

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.