FDA.reportPublic FDA data

N/A

Primary DI
10887529000103
Brand
N/A
Company
Bistos Co., Ltd.
Model
BT-300
Catalog number
OSD-15300-001
Device description
BT-300 is the fetal monitor that measures the fetal heart rate(FHR) which may be evaluated to predict fetal status and uterine contraction. BT-300 irradiates ultrasound wave to the abdomen of a pregnant woman, and detects the Doppler frequency signal reflected from the heart of the fetus.
Published
2016-06-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

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
K052190000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052190000FETAL MONITOR, MODELS BT-300 AND BT-200Bistos Co., Ltd.2005-10-04HGM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887529000250PackageGS11In Commercial Distribution
10887529000103PackageGS11In Commercial Distribution
00887529000106PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887529000250008875290002508875290002500887529000250
1088752900010310887529000103
00887529000106008875290001068875290001060887529000106

GMDN Terms#

Term, Definition table
TermDefinition
Cardiotocograph transducerA device that converts birthing contractions to electrical signals and is used together with cardiotocograph (CTG) which displays the signals. It is a dedicated transducer (a tocodynamometer) that is usually strapped onto the womans abdomen. 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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
689908411
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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

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