FDA.reportPublic FDA data

Babyleo TN500

Primary DI
04048675641308
Brand
Babyleo TN500
Company
Drägerwerk AG & Co. KGaA
Model
2M61100
Published
2026-03-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
FMTWarmer, Infant Radiant
FMZIncubator, Neonatal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMTWarmer, Infant RadiantGeneral Hospital2
FMZIncubator, NeonatalGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251619000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251619000Babyleo TN500Drägerwerk AG & Co. KGaA2026-02-13FMZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048675641308PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048675641308040486756413084048675641308

GMDN Terms#

Term, Definition table
TermDefinition
Conventional infant incubatorA mains electricity (AC-powered) unit designed to provide an enclosed controlled environment to maintain appropriate temperature and humidity levels mainly for premature infants and other newborns who cannot effectively regulate their body temperature. It typically consists of a clear removable plastic hood with a mattress. It typically includes a means to warm the infant such as providing heated air (either by natural flow or forced) or through a warm water mattress; temperature controls that work automatically either by measuring the air temperature or through a temperature sensor attached to the infant skin; and humidity controls. The device is intended to remain in a hospital ward.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315578914
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048675542148Evita V80084225002023-06-02
04048675548744Evita V60084223002023-06-02
04048675448884Sample Line Set (10pcs)82902862026-02-16
04048675429302Scio Four, Oxi plus68718012015-11-04
04048675034643Connector M34X1.5, 9/162M866802026-02-04
04048675034735"Adapter 9/16"" to 6mm"MP004162026-02-04
04048675229674Apollo86065002015-10-24
04048675429319Scio Four, plus68718022015-11-04
04048675429326Scio Four, Oxi68718032015-11-04
04048675420989APack Watertrap AdultMP016822015-10-24
04048675013532CORRUGATED BELLOWS K84100792015-10-24
04048675010470Corrugated hose 10/10 (N/P) 1984107092015-10-24
04048675022305Hytrel hose 13/13 (N/P) 6584108142015-10-24
04048675041061Headgear disp.,soft rub.,smallMP015612015-10-24
04048675041078Headgear disp.,soft rub.,largeMP015622015-10-24
04048675126317AnesthesiaSet Flex Latexfrei USMP003232015-10-24
04048675253365VentStar Helix dual heatedMP026062015-10-24
04048675253372VentStar Helix heatedMP026072015-10-24
04048675382256Mask ventkit O2Star fixed M/LMP019232015-10-24
04048675382423Mask ventkit O2Star fixed SMP019362015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10889483577363AirLife™AirLife Finland OyFMZ2025-03-26
10889483577370AirLife™AirLife Finland OyFMZ2025-03-26
10889483587881AirLife™AirLife Finland OyFMT2025-03-26
10889483587904AirLife™AirLife Finland OyFMT2025-03-26
20889483577360AirLife™AirLife Finland OyFMZ2025-03-26
20889483577377AirLife™AirLife Finland OyFMZ2025-03-26
10889483577387AirLife™AirLife Finland OyFMZ2025-03-26
20889483587888AirLife™AirLife Finland OyFMT2025-03-26
20889483587901AirLife™AirLife Finland OyFMT2025-03-26
10889483587959AirLife™AirLife Finland OyFMT2025-03-26
B510A31860ADVANCED NEONATAL INCUBATORADVANCED INSTRUMENTATIONS, INC.FMZ2025-02-07
B510A31861ADVANCED NEONATAL INCUBATORADVANCED INSTRUMENTATIONS, INC.FMZ2025-02-07
B510A4051ADVANCED INFANT WARMERADVANCED 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
04048675436607Babyleo TN500Drägerwerk AG & Co. KGaAFMT2024-03-09
00865648000313NuBorne Infant WarmerINTERNATIONAL BIOMEDICAL, LTD.FMT2023-06-20
04049098099042Babyroo TN300 Infant Radiant WarmerDRAEGER MEDICAL SYSTEMS, INC.FMT2023-06-08
00749756379205DeRoyalDEROYAL INDUSTRIES, INC.FMT2023-02-06
50749756379200DeRoyalDEROYAL INDUSTRIES, INC.FMT2023-02-06
00860007476310ATOM Medical USA, Disposable ProbeAtom Medical Usa, LLCFMT2022-02-08
00860007476310ATOM Medical USA, Disposable ProbeAtom Medical Usa, LLCFMZ2022-02-08
00195278358363GIRAFFE PANDA DISPOSABLE SKIN TEMPERATUREDatex-Ohmeda, Inc.FMZ2021-11-10
00195278358363GIRAFFE PANDA DISPOSABLE SKIN TEMPERATUREDatex-Ohmeda, Inc.FMT2021-11-10
00749756772358DeRoyalDEROYAL INDUSTRIES, INC.FMT2021-07-12
30749756772359DeRoyalDEROYAL INDUSTRIES, INC.FMT2021-07-12
00763000374716Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSFMZ2021-05-21
00763000374723Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSFMZ2021-05-21