FDA.reportPublic FDA data

N/A

Primary DI
00887529000069
Brand
N/A
Company
Bistos Co., Ltd.
Model
BT-350E
Catalog number
MKT-350-1509
Device description
BT-350 is the fetal monitor that measures the fetal heart rate(FHR) and uterine contraction. Using these parameters, the medical team can monitor fetal status and check uterine contraction degree.
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
HGMSystem, Monitoring, Perinatal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGMSystem, Monitoring, PerinatalObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103545000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103545000BT-350Bistos Co., Ltd.2011-05-13HGM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887529000304PackageGS11In Commercial Distribution
10887529000066PackageGS11In Commercial Distribution
00887529000069PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887529000304008875290003048875290003040887529000304
1088752900006610887529000066
00887529000069008875290000698875290000690887529000069

GMDN Terms#

Term, Definition table
TermDefinition
Tocodynamometer probeA pressure transducer intended to be placed on the abdomen of a labouring woman to convert uterine birthing contractions to electrical signals; the signals are typically displayed by a cardiotocograph (CTG). This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity5 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 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
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
18800012315036Hi bebe superBT-150S2021-06-08

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