FDA.reportPublic FDA data

BIONIX DEVELOPMENT CORPORATION

Primary DI
08599110040133
Brand
BIONIX DEVELOPMENT CORPORATION
Company
M&H Medical Holdings, Inc.
Model
NP-1100
Catalog number
1100
Device description
Swaddler for PhotoTherapy, preemie
Published
2016-10-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PDHblanket, neonatal phototherapy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PDHBlanket, Neonatal PhototherapyGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123411000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123411000LITTLE ANGELS SWADDLING BLANKETBionix Development Corp.2013-03-07PDH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08599110040119PackageGS110Not in Commercial Distribution
08599110040133PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08599110040119085991100401198599110040119
08599110040133085991100401338599110040133

GMDN Terms#

Term, Definition table
TermDefinition
Blanket/pad infant phototherapy unitA 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 light source that connects to a 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. It is intended for use in the home and a clinical setting.

Contacts#

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

Regulatory Flags#

DUNS number
602736795
Device count
1
DM exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08599110040140BIONIX DEVELOPMENT CORPORATIONNP-110511052016-10-25
08599110040065BIONIX DEVELOPMENT CORPORATIONDG-9119112016-10-26
08599110040072BIONIX DEVELOPMENT CORPORATIONDG-9129122016-10-26
08599110040089BIONIX DEVELOPMENT CORPORATIONDG-9139132016-10-26
08599110040096BIONIX DEVELOPMENT CORPORATIONDG-9219212016-10-26
08599110040102BIONIX DEVELOPMENT CORPORATIONDG-9229222016-10-26
08599110040010BIONIX DEVELOPMENT CORPORATIONDG-9119112016-10-26
08599110040027BIONIX DEVELOPMENT CORPORATIONDG-9129122016-10-26
08599110040034BIONIX DEVELOPMENT CORPORATIONDG-9139132016-10-26
08599110040041BIONIX DEVELOPMENT CORPORATIONDG-9219212016-10-26
08599110040058BIONIX DEVELOPMENT CORPORATIONDG-9229222016-10-26
08599110040119BIONIX DEVELOPMENT CORPORATIONNP-110011002016-10-25
08599110040126BIONIX DEVELOPMENT CORPORATIONNP-110511052016-10-25
00859911004917BIONIX DEVELOPMENT CORPORATIONGF-0951095102019-03-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B510PT3000ADVANCED PHOTOTHERAPY LAMP ADVANCED INSTRUMENTATIONS, INC.PDH2025-08-21
00859911004351BIONIX DEVELOPMENT CORPORATIONBionix, LLCPDH2017-02-22
00859911004368BIONIX DEVELOPMENT CORPORATIONBionix, LLCPDH2017-02-22
00859911004276Swaddler for PhototherapyBionix, LLCPDH2017-02-01
00859911004283Swaddler for PhototherapyBionix, LLCPDH2017-02-01
00607411930379N/ASALTER LABSPDH2017-01-30
00607411930386N/ASALTER LABSPDH2017-01-30
00607411930393N/ASALTER LABSPDH2017-01-30
08599110040140BIONIX DEVELOPMENT CORPORATIONM&H Medical Holdings, Inc.PDH2016-10-25
08599110040119BIONIX DEVELOPMENT CORPORATIONM&H Medical Holdings, Inc.PDH2016-10-25
08599110040126BIONIX DEVELOPMENT CORPORATIONM&H Medical Holdings, Inc.PDH2016-10-25