ADVANCED PHOTOTHERAPY LAMP

GUDID B510PT3000

ADVANCED INSTRUMENTATIONS, INC.

Overhead infant phototherapy unit
Primary Device IDB510PT3000
NIH Device Record Key1d07bd4c-55cc-4461-b35d-5fec8fdb0e52
Commercial Distribution StatusIn Commercial Distribution
Brand NameADVANCED PHOTOTHERAPY LAMP
Version Model NumberPT-3000
Company DUNS608736880
Company NameADVANCED INSTRUMENTATIONS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB510PT3000 [Primary]

FDA Product Code

PDHBlanket, Neonatal Phototherapy

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-29
Device Publish Date2025-08-21

Devices Manufactured by ADVANCED INSTRUMENTATIONS, INC.

B510PT3000 - ADVANCED PHOTOTHERAPY LAMP 2025-08-29
B510PT3000 - ADVANCED PHOTOTHERAPY LAMP 2025-08-29
B510PM200MPRO1 - ADVANCED PATIENT MONITOR2025-07-31
B510V1000 - ADVANCED VENTILATOR2025-02-18
B510A31860 - ADVANCED NEONATAL INCUBATOR2025-02-17
B510A31861 - ADVANCED NEONATAL INCUBATOR2025-02-17
B510A4051 - ADVANCED INFANT WARMER2025-02-17
B510AM60001 - ADVANCED GAS-MACHINE ANESTHESIA2025-02-17
B510FM9000 - ADVANCED FETAL MONITOR2025-02-17

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