FDA.reportPublic FDA data

Mothership Wireless Transducers, Button Style

Primary DI
00852189007390
Brand
Mothership Wireless Transducers, Button Style
Company
TENACORE HOLDINGS, INC.
Model
F1
Device description
Kit for Fetal Ultrasonic and Tocodynamometer Monitoring includes F1 Mothership Wireless Fetal Ultrasound Transducer, Button-Style, F1 Mothership Wireless Tocodynamometer Transducer, Button Style, and F1 Mothership Wireless Fetal Transducer Base Station.
Published
2017-10-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
HGMSystem, Monitoring, Perinatal

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852189007390PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852189007390008521890073908521890073900852189007390

GMDN Terms#

Term, Definition table
TermDefinition
Cardiotocography telemetric monitoring system receiverA mains electricity (AC-powered) component of a cardiotocography telemetric monitoring system designed to wirelessly receive, consolidate, and display foetal heart rate and uterine contraction signals from a transmitter connected to a patient, typically ambulatory, for viewing at a receiving location (e.g., central station, bedside monitor).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature50 Degrees Fahrenheit104 Degrees Fahrenheit
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature14 Degrees Fahrenheit131 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
138781799
Device count
1
DM exempt
true
Kit
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852189007000TenacoreTFCT-PH06-23032016-10-17
00852189007017TenacoreTFCT-PH05-23032016-09-29
00852189007024TenacoreTFCT-CM03-02012016-10-17
00852189007031Tenacore TFCT-CM03-01012016-10-17
00852189007048TenacoreTFCT-CM02-01012016-10-17
00852189007055TenacoreTFCU-PH06-23032016-09-29
00852189007086TenacoreTFCU-CM03-02012016-10-18
00852189007093TenacoreTFCU-CM03-01012016-10-18
00852189007109TenacoreTFCU-CM02-01012016-09-29
00852189007147TenacoreTFCU-CM01-21012016-10-18
00852189007062Veevo1500 Series2016-09-29
00852189007079TenacoreTFCU-PH05-23032016-10-18
00852189007116Veevo3000 Series2016-09-29
00852189007123Veevo1510 Series2016-09-29
00852189007130Veevo1520 series2016-09-29
00852189007154Veevo7000 Series2016-09-29
00861269000237Veevo800 Series2016-09-29
00861269000282Veevo810 Series2016-09-29
00861269000299Veevo820 Series2016-09-29
00861269000206Tenacore12015-09-24

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