Home GUDID 08599110040126 BIONIX DEVELOPMENT CORPORATION
Primary DI 08599110040126
Brand BIONIX DEVELOPMENT CORPORATION
Company M&H Medical Holdings, Inc.
Model NP-1105
Catalog number 1105
Device description Swaddler for PhotoTherapy, normal
Published 2016-10-25
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name PDH blanket, neonatal phototherapy
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PDH Blanket, Neonatal Phototherapy General Hospital 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08599110040126 Package GS1 10 Not in Commercial Distribution 08599110040140 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08599110040126 08599110040126 8599110040126 08599110040140 08599110040140 8599110040140
GMDN Terms# 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.
Regulatory Flags# DUNS number 602736795 Device count 1 DM exempt true Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# 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 00859911004368 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
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