FDA.reportPublic FDA data

Tenacore

Primary DI
00852189007079
Brand
Tenacore
Company
TENACORE HOLDINGS, INC.
Model
TFCU-PH05-2303
Device description
HP/Philips M1356A Ultrasound W/HORSESHOE AND KNOB
Published
2016-10-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00852189007079PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852189007079008521890070798521890070790852189007079

GMDN Terms#

Term, Definition table
TermDefinition
Vacuum suction regulator/regulation set, general-purposeA noninvasive device/collection of noninvasive devices designed to connect to the terminal unit (wall outlet) of a vacuum pipeline system to control the degree of negative pressure during the evacuation of fluids, mucus, or solids during a range of clinical applications (e.g., not dedicated to thoracic suction). It allows continuous and/or intermittent suction at variable levels, incorporates a manometer and controls for monitoring/adjusting the level of suction, and may include collection containers, tubing or a stand/mount; it does not include patient contact devices (e.g., handpiece/tip, catheter).

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
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
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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