BIONIX DEVELOPMENT CORPORATION

Contact Domains#

Code, Name table
Code	Name
PDH	blanket, neonatal phototherapy

Code, Device, Specialty table
Code	Device	Specialty	Class
PDH	Blanket, Neonatal Phototherapy	General Hospital	2

Submission, Supplement table
Submission	Supplement
K123411	000

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
K123411	000	LITTLE ANGELS SWADDLING BLANKET	Bionix Development Corp.	2013-03-07	PDH

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
00859911004368	Primary	GS1	0

Source identifier, GTIN-14 normalized, UPC-A table
Source identifier	GTIN-14 normalized	UPC-A	EAN-13
00859911004368	00859911004368	859911004368	0859911004368

Term, Definition table
Term	Definition
Blanket/pad infant phototherapy unit	A device designed to emit a blue light in the visible wavelength of around 425-475 nm to treat neonatal jaundice (or hyperbilirubinemia). It consists of a fibreoptic-light source that connects through a flexible fibreoptic cable to a transparent blanket-like wrap or pad which emits the light and covers or encloses the neonate's body. Exposure to this device will alter the bilirubin through photo oxidation and configurational and structural isomerization allowing the body function to dispose of it naturally. This device can be suitable for home-use.

Method table
Method

Phone, Email table
Phone	Email
+1(800)551-7096	xxx@xxx.xxx

Primary DI, Brand, Model table
Primary DI	Brand	Model	Catalog	Published
00859911004184	Bionix Development Corporation	3700	3700	2017-01-28
00859911004498	Safe Ear Curette™ Variety Kit	5777	5777	2021-12-10
00859911004429	Green MicroLoop®	1222	1222	2021-12-10
00859911004436	Orange ControLoop®	2999	2999	2021-12-10
00859911004443	Red AngleLoop®	3444	3444	2021-12-10
00859911004450	Purple VersaLoop®	4111	4111	2021-12-10
00859911004467	Blue InfantScoop®	4888	4888	2021-12-10
00859911004474	Yellow CeraSpoon®	6333	6333	2021-12-10
00859911004481	White FlexLoop®	9555	9555	2021-12-10
00859911004528	Lighted AngleLoop®	2210	2210	2021-12-10
00859911004535	Lighted MicroLoop®	2220	2220	2021-12-10
00859911004542	Lighted WaveCurette™	2230	2230	2021-12-10
00859911004559	Lighted FlexLoop®	2240	2240	2021-12-10
00859911004566	Lighted Ear Curette™ Variety Pack	2245	2245	2021-12-10
00859911004573	Lighted CeraSpoon®	2250	2250	2021-12-10
00859911004580	Lighted InfantScoop®	2260	2260	2021-12-10
00859911004597	Lighted VersaLoop®	2270	2270	2021-12-10
00859911004603	Lighted CeraPik™	2280	2280	2021-12-10
00859911004702	Lighted Forceps for Foreign Body Removal	2750	2750	2021-12-10
00859911004726	Lighted Placement Tool	2850	2850	2022-08-08

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
B510PT3000	ADVANCED PHOTOTHERAPY LAMP	ADVANCED INSTRUMENTATIONS, INC.	PDH	2025-08-21
00859911004351	BIONIX DEVELOPMENT CORPORATION	Bionix, LLC	PDH	2017-02-22
00859911004276	Swaddler for Phototherapy	Bionix, LLC	PDH	2017-02-01
00859911004283	Swaddler for Phototherapy	Bionix, LLC	PDH	2017-02-01
00607411930379	N/A	SALTER LABS	PDH	2017-01-30
00607411930386	N/A	SALTER LABS	PDH	2017-01-30
00607411930393	N/A	SALTER LABS	PDH	2017-01-30
08599110040133	BIONIX DEVELOPMENT CORPORATION	M&H Medical Holdings, Inc.	PDH	2016-10-25
08599110040140	BIONIX DEVELOPMENT CORPORATION	M&H Medical Holdings, Inc.	PDH	2016-10-25
08599110040119	BIONIX DEVELOPMENT CORPORATION	M&H Medical Holdings, Inc.	PDH	2016-10-25
08599110040126	BIONIX DEVELOPMENT CORPORATION	M&H Medical Holdings, Inc.	PDH	2016-10-25