FDA.reportPublic FDA data

Tenacore

Primary DI
00852189007031
Brand
Tenacore
Company
TENACORE HOLDINGS, INC.
Model
TFCT-CM03-0101
Device description
Corometrics Nautilus TOCO for 116, 118, 120 series, 150, 170 series monitors W/WING
Published
2016-10-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K043075000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K043075000TENACORE TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORINGTenacore Holdings, Inc.2005-08-18HGM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852189007031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852189007031008521890070318521890070310852189007031

GMDN Terms#

Term, Definition table
TermDefinition
CardiotocographA mains electricity (AC-powered) patient monitor that displays the relationship between maternal labour and the foetal heart rate by means of combining and coordinating uterine contraction and foetal heart monitoring during the perinatal period. The uterine contractions are usually recorded using a tocodynamometer (a pressure transducer) which is strapped onto the mother's abdomen. Commonly known as a tococardiograph or a cardiotocograph (CTG) machine, the heart rate is typically measured with a dedicated ultrasound transducer.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
138781799
Device count
1
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
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
00861269000213Tenacore12015-09-24

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Primary DI, Brand, Company table
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