FDA.reportPublic FDA data

N/A

Primary DI
00887529000137
Brand
N/A
Company
Bistos Co., Ltd.
Model
BT-500
Catalog number
MKT-500-1509
Device description
BT-500 Infant incubator consists of Hood, Control Box, LCD external monitor and main body with stand ( optional), This device incorporates two sensors to control Humidity, and Temperature inside the Hood and monitors the Air Conditions, and controls Circulation with proper temperature.
Published
2016-06-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMZIncubator, Neonatal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMZIncubator, NeonatalGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132543000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132543000INFANT INCUBATORBistos Co., Ltd.2014-07-03FMZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887529000212PackageGS11In Commercial Distribution
10887529000134PackageGS11In Commercial Distribution
00887529000137PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887529000212008875290002128875290002120887529000212
1088752900013410887529000134
00887529000137008875290001378875290001370887529000137

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature20 Degrees Celsius30 Degrees Celsius
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
949-614-8745fshurjoon@bistos.co.kr

Regulatory Flags#

DUNS number
689908411
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887529000410Hi bebe superBT-150B2026-05-15
00887529000502N/ABT-10002026-05-15
00887529000519BT-1000 electrodeN/A2026-05-15
08800012315022Hi bebe superBT-150L2021-06-08
08800012315039Hi bebe superBT-150S2021-06-08
00887529000014Hi-dopBT-200VOSD-14200V-0012016-06-14
00887529000021Hi-bebeBT-200SMKT-200-15012016-06-03
00887529000038Hi-bebeBT-200LMKT-200-15012016-06-01
00887529000045N/ABT-200TMKT-200-15012016-06-14
00887529000052N/ABT-350LMKT-350-15092016-06-03
00887529000069N/ABT-350EMKT-350-15092016-06-03
00887529000083N/ABT-220LOSD-14220-0012016-06-03
00887529000090N/ABT-220COSD-14220-0012016-06-03
00887529000106N/ABT-300OSD-15300-0012016-06-14
00887529000199Hi-bebeBT-200C2018-03-16
00887529000465Duo Double Electric Breast PumpAAA00212021-10-28
08800012345012BiliTouchTMMotif Phototherapy Blanket2021-06-09
18800012345019BiliTouchTMMotif Phototherapy Blanket2021-06-09
08800012345005Infant Phototherapy EquipmentBT-4502021-06-08
18800012315029Hi bebe superBT-150L2021-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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
00860007476310ATOM Medical USA, Disposable ProbeAtom Medical Usa, LLCFMZ2022-02-08
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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
00643169912205Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSFMZ2019-06-08