FDA.reportPublic FDA data

ADVANCED PHOTOTHERAPY LAMP

Primary DI
B510PT3000
Brand
ADVANCED PHOTOTHERAPY LAMP
Company
ADVANCED INSTRUMENTATIONS, INC.
Model
PT-3000
Published
2025-08-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
PDHBlanket, Neonatal Phototherapy

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B510PT3000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Overhead infant phototherapy unitA mains electricity (AC-powered) device designed to emit a blue light in the visible wavelength of around 425-475 nm to treat neonatal jaundice (hyperbilirubinemia). It consists of an overhead lamp consisting of several, daylight, cool white, blue, or special blue fluorescent light tubes and a Plexiglas shield placed between the phototherapy lights and the newborn to filter out ultraviolet (UV) radiation. Exposure to this device will alter the bilirubin through photo-oxidation, and configurational and structural isomerization, allowing the body to dispose of it naturally. It will typically have a built-in timer, but some may have a separate timer unit connected.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
608736880
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B510SL700700LED1ADVANCED SURGICAL LAMP SL700/700 LED2026-03-24
D510DUS6000ADVANCED DIGITAL PORTABLE ULTRASONIC SYSTEM DUS-60002026-03-24
B510D100ADVANCED MONITOR DEFIBRILLATORD100+2026-01-14
B510PM200MPRO1ADVANCED PATIENT MONITORPM-200M PRO2025-07-23
B510V1000ADVANCED VENTILATORV-10002025-02-10
B510A31860ADVANCED NEONATAL INCUBATORA31862025-02-07
B510A31861ADVANCED NEONATAL INCUBATORA3186+2025-02-07
B510A4051ADVANCED INFANT WARMERA40512025-02-07
B510AM60001ADVANCED GAS-MACHINE ANESTHESIAAM-6000+2025-02-07
B510FM9000ADVANCED FETAL MONITORFM-90002025-02-07
B510PT2000ADVANCED LED PHOTOTHERAPY LAMPPT-20002025-02-07
B510PT5000ADVANCED LED PHOTOTHERAPY LAMPPT-50002025-02-07
B510A3158ADVANCED TRANSPORT INCUBATORA31582025-02-04
B510IP200ADVANCED INFUSION PUMPIP-2002025-02-04
B510PMMAX13ADVANCED PATIENT MONITORPM-Max132024-12-19
B510PMMAX15ADVANCED PATIENT MONITORPM-Max152024-12-19
B510PM2000A1ADVANCED PATIENT MONITORPM-2000A2020-04-16
B510PM2000APRO1ADVANCED PATIENT MONITORPM-2000A PRO2020-04-16
B510PM2000M1ADVANCED PATIENT MONITORPM-2000M2020-04-16
B510PM2000XL1ADVANCED PATIENT MONITORPM-2000XL2020-04-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08599110040133BIONIX DEVELOPMENT CORPORATIONM&H Medical Holdings, Inc.PDH2016-10-25
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