Unit, Neonatal Phototherapy

Product Code: LBI

General Hospital Ultraviolet Medical Products

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 880.5700


Radiation TypeOptical
Radition SafetyNone
Annual ReportsNo

Products Classified as LBI

2646Unit, Neonatal PhototherapyNeonatal Phototherapy Unit.

Total Product Life Cycle (TPLC) Devices

2646Unit, Neonatal PhototherapyNeonatal Phototherapy Unit.

FDA Consensus Standards

Unit, Neonatal Phototherapy [36932]21 CFR §880.5700 🔎

Pre-market Notifications for LBI

K210289Infant Phototherapy EquipmentBistos Co., Ltd.
K190899Bili-hutLittle Sparrows Technologies, Inc.
K182178NeoBLUE Blanket LED Phototherapy SystemNatus Medical Incorporated
K172656BiliLuxDraeger Medical Systems, Inc.
K170585SkylifeNeoLight, LLC
K163526Bilicocoon™ Phototherapy SystemNEOMEDLIGHT
K160745NeoBLUE Compact LED Phototherapy SystemNATUS MEDICAL INCORPORATED
K160305NeoBLUE® LED Phototherapy SystemNatus Medical Incorporated
K160238Airborne Phototherapy LightINTERNATIONAL BIOMEDICAL
K142332BT-400Bio-Med USA
K131196INFANT PHOTOTHERAPY BILITRON SKY 5006FANEM LDA
K120820GIRAFFE BLUE SPOT PT LITELUMITEX, INC.
K120168LULLABY LED PHOTTHERAPY SYSTEMWIPRO GE HEALTHCARE PRIVATE, LTD.
K113206NANOBLUTM 500Draeger Medical Systems, Inc.
K111547BILI-THERAPY PAD TYPEATOM MEDICAL CORPORATION

Global Unique Device Identification Database

00382830053686Unit, Neonatal Phototherapy
00382830053198Unit, Neonatal Phototherapy
00382830016773Unit, Neonatal Phototherapy
00382830015523Unit, Neonatal Phototherapy
00382830015516Unit, Neonatal Phototherapy
00382830015431Unit, Neonatal Phototherapy
00382830015424Unit, Neonatal Phototherapy
00382830015417Unit, Neonatal Phototherapy
00382830015394Unit, Neonatal Phototherapy
00382830011594Unit, Neonatal Phototherapy
00382830005678Unit, Neonatal Phototherapy
00382830003995Unit, Neonatal Phototherapy
00382830003971Unit, Neonatal Phototherapy
00382830003964Unit, Neonatal Phototherapy
00812432020484Unit, Neonatal Phototherapy

Maude Adverse Events

OLYMPIC BILI-BASSINETNATUS MEDICAL INCORPORATED2020-01-16
BILLSOFTGENERAL ELECTRIC CO.2019-10-25
NEOBLUENATUS MEDICAL INCORPORATED2019-08-23
THE WALLABY 3 BILI BLANKETPHILIPS RESPIRONICS / PHILIPS MEDICAL SYSTEMS2019-07-23
LULLABY LED PHOTOTHERAPYWIPRO GE HEALTHCARE PRIVATE LTD.2019-04-24
BILISOFTOHMEDA MEDICAL2019-04-18
NEOBLUENATUS MEDICAL INCORPORATED2019-02-25
NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEMNATUS MEDICAL INCORPORATED2018-08-17
NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEMNATUS MEDICAL INCORPORATED2018-08-17
NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEMNATUS MEDICAL INCORPORATED2018-08-17
PHOTO-THERAPY 4000DRAEGER MEDICAL SYSTEMS, INC.2018-08-10
NEOBLUE LED PHOTOTHERAPY SYSTEMNATUS MEDICAL INCORPORATED2018-08-10
NEOBLUE COZY LED PHOTOTHERAPY SYSTEMNATUS MEDICAL INCORPORATED2018-08-09
NEOBLUE COZYNATUS MEDICAL INC.2018-04-04
NEOBLUE 3 LED PHOTOTHERAPY SYSTEMNATUS MEDICAL INCORPORATED2018-03-22
NEOBLUE 3 LED PHOTOTHERAPY SYSTEMNATUS MEDICAL INCORPORATED2018-03-21
NEOBLUE BLANKETNATUS MEDICAL INC.2018-02-23
BILITX LIGHT SOURCEPHILIPS MEDICAL SYSTEMS2018-02-19
NEOBLUE 3 LED PHOTOTHERAPY SYSTEMNATUS MEDICAL INCORPORATED2018-01-30
NEOBLUE MINI LED PHOTOTHERAPY SYSTEMNATUS MEDICAL INCORPORATED2018-01-30
NEOBLUENATUS MEDICAL INCORPORATED2018-01-25
NEOBLUENATUS MEDICAL INCORPORATED2018-01-24
NEOBLUENATUS MEDICAL INCORPORATED2018-01-24
NEOBLUE COZY LED PHOTOTHERAPY SYSTEMNATUS MEDICAL INCORPORATED2018-01-24
NEOBLUENATUS MEDICAL INCORPORATED2018-01-24
NEOBLUENATUS MEDICAL INCORPORATED2018-01-24
NEOBLUENATUS MEDICAL INCORPORATED2018-01-18
NEOBLUENATUS MEDICAL INCORPORATED2018-01-18
NEOBLUENATUS MEDICAL INCORPORATED2018-01-16
NEOBLUENATUS MEDICAL INCORPORATED2018-01-16
NEOBLUENATUS MEDICAL INCORPORATED2018-01-15
NEOBLUENATUS MEDICAL INCORPORATED2018-01-12
NEOBLUENATUS MEDICAL INCORPORATED2018-01-12
NEOBLUENATUS MEDICAL INCORPORATED2018-01-12
NEOBLUENATUS MEDICAL INCORPORATED2018-01-12
NEOBLUENATUS MEDICAL INCORPORATED2018-01-12
NEOBLUENATUS MEDICAL INCORPORATED2018-01-12
NEOBLUENATUS MEDICAL INCORPORATED2018-01-10
NEOBLUENATUS MEDICAL INCORPORATED2018-01-10
NEOBLUENATUS MEDICAL INCORPORATED2018-01-10
NEOBLUENATUS MEDICAL INCORPORATED2018-01-09
NEOBLUENATUS MEDICAL INCORPORATED2018-01-09
NEOBLUENATUS MEDICAL INCORPORATED2018-01-09
NEOBLUENATUS MEDICAL INCORPORATED2018-01-04
NEOBLUENATUS MEDICAL INCORPORATED2017-12-29
NEOBLUENATUS MEDICAL INCORPORATED2017-12-29
NEOBLUENATUS MEDICAL INCORPORATED2017-12-28
NEOBLUENATUS MEDICAL INCORPORATED2017-12-27
BILI LITENATUS MEDICAL INCORPORATED2017-12-27
NEOBLUENATUS MEDICAL INCORPORATED2017-12-26
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