FDA.reportPublic FDA data

ADVANCED INFANT WARMER

Primary DI
B510A4051
Brand
ADVANCED INFANT WARMER
Company
ADVANCED INSTRUMENTATIONS, INC.
Model
A4051
Published
2025-02-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FMZIncubator, Neonatal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMZIncubator, NeonatalGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B510A4051PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Infant warmerA mains electricity (AC-powered) mobile device that contains an infrared (IR) heating element(s) designed to emit controlled, evenly distributed overhead heat to the body of a newborn/infant patient requiring supplemental heat. This device is equipped with wheels so that it can easily be moved to different areas of a room, ward, or department.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
608736880
Device count
1
Premarket exempt
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
B510PT3000ADVANCED PHOTOTHERAPY LAMP PT-30002025-08-21
B510PM200MPRO1ADVANCED PATIENT MONITORPM-200M PRO2025-07-23
B510V1000ADVANCED VENTILATORV-10002025-02-10
B510A31860ADVANCED NEONATAL INCUBATORA31862025-02-07
B510A31861ADVANCED NEONATAL INCUBATORA3186+2025-02-07
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
04048675641308Babyleo TN500Drägerwerk AG & Co. KGaAFMZ2026-03-23
10889483577363AirLife™AirLife Finland OyFMZ2025-03-26
10889483577370AirLife™AirLife Finland OyFMZ2025-03-26
20889483577360AirLife™AirLife Finland OyFMZ2025-03-26
20889483577377AirLife™AirLife Finland OyFMZ2025-03-26
10889483577387AirLife™AirLife Finland OyFMZ2025-03-26
B510A31860ADVANCED NEONATAL INCUBATORADVANCED INSTRUMENTATIONS, INC.FMZ2025-02-07
B510A31861ADVANCED NEONATAL INCUBATORADVANCED INSTRUMENTATIONS, INC.FMZ2025-02-07
04942962610858V-2200 Infant Incubator ATOM MEDICAL CORPORATIONFMZ2024-10-29
04942962616102Neo-Servo i Atom Infant Incubator Model 102ATOM MEDICAL CORPORATIONFMZ2024-10-29
04942962674065V-2100G Advanced Infant Incubator ATOM MEDICAL CORPORATIONFMZ2024-10-29
04048675436607Babyleo TN500Drägerwerk AG & Co. KGaAFMZ2024-03-09
00860007476310ATOM Medical USA, Disposable ProbeAtom Medical Usa, LLCFMZ2022-02-08
00195278358363GIRAFFE PANDA DISPOSABLE SKIN TEMPERATUREDatex-Ohmeda, Inc.FMZ2021-11-10
00763000374716Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSFMZ2021-05-21
00763000374723Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSFMZ2021-05-21
10190752179608AirlifeAirLife Finland OyFMZ2021-02-26
10190752179615AirlifeAirLife Finland OyFMZ2021-02-26
20190752179605AirlifeVYAIRE MEDICAL, INC.FMZ2021-02-26
70190752179617AirlifeVYAIRE MEDICAL, INC.FMZ2021-02-26
10190752179622AirlifeAirLife Finland OyFMZ2021-02-26
10190752106130Multi-Link™AirLife Finland OyFMZ2021-01-13
10190752106147Multi-Link™AirLife Finland OyFMZ2021-01-13
20190752106137Multi-Link™Vyaire Medical OyFMZ2021-01-13
20190752106144Multi-Link™Vyaire Medical OyFMZ2021-01-13
10190752106161Multi-Link™AirLife Finland OyFMZ2021-01-13
00643169912199Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSFMZ2019-06-08
00643169912182Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSFMZ2019-06-01
04048675020530Isolette 8000 plusDRAEGER MEDICAL SYSTEMS, INC.FMZ2018-12-03
00854758006179Access Medical ProbesTARRY MEDICAL PRODUCTS, INC.FMZ2018-09-13