FDA.report

EcoVue HV

Primary DI
30851809002020
Brand
EcoVue HV
Company
HR PHARMACEUTICALS INC.
Model
380
Catalog number
380
Device description
Sterile Ultrasound Gel High Viscosity
Published
2020-09-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
MUIMedia, coupling, ultrasound

Product Code Classifications

CodeDeviceSpecialtyClass
MUIMedia, Coupling, UltrasoundRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10851809002026PackageGS148In Commercial Distribution
20851809002023PackageGS1100In Commercial Distribution
30851809002020PackageGS16In Commercial Distribution
40851809002027PackageGS14In Commercial Distribution
80851809002025PackageGS11In Commercial Distribution
00851809002029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1085180900202610851809002026
2085180900202320851809002023
3085180900202030851809002020
4085180900202740851809002027
8085180900202580851809002025
00851809002029008518090020298518090020290851809002029

GMDN Terms

TermDefinition
Coupling gel, sterileA sterile medium designed to be applied to a patient's skin surface to provide a coupling between an ultrasound transducer and the patient, allowing for the emission and reception of ultrasonic waves that pass through the skin during an ultrasound examination requiring sterile procedure. It is in the form of a non-sticky, drip resistant, fluid-like gel that has been thermally sterilized (contains no degradation products of radiation sterilization) that also assists the operator's ability to move the ultrasound transducer (probe) smoothly over the skin to better scan the site of interest. After application, this device cannot be reused.

Device Sizes

TypeValueUnit
Weight20Gram

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(717)252-1110sbenser@hrpharma.com

Regulatory Flags

DUNS number
828918164
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
50850058254673EZ-Advancer®AKC142026-03-06
50850058254680TruAdvance™TAC142026-03-06
10850067913006TruLockTLFS302026-03-06
10850067913013TruLockTLFS562026-03-06
50850058254451EZ-Protect™10108H2026-02-05
00850058254463EZ-Protect™10110H2026-02-05
50850058254475EZ-Protect™10112H2026-02-05
50850058254482EZ-Protect™10114H2026-02-05
50850058254499EZ-Protect™10116H2026-02-05
50850058254505EZ-Protect™10118H2026-02-05
50850058254512EZ-Protect™12108H2026-02-05
50850058254529EZ-Protect™12110H2026-02-05
50850058254536EZ-Protect™12112H2026-02-05
50850058254543EZ-Protect™12114H2026-02-05
50850058254550EZ-Protect™12116H2026-02-05
50850058254567EZ-Protect™12118H2026-02-05
50850045818468TruAdvance®FTDS14UM2025-12-22
50850045818475TruAdvance®FTDS16UM2025-12-22
50850045818482TruAdvance®FTDS18UM 2025-12-22
50850058254888TruAdvanceFTTS14UM2025-09-11

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00197344130279MEDLINEMEDLINE INDUSTRIES, INC.MUI2026-01-23
20665973032638DukalDukal LLCMUI2026-01-12
20665973032645DukalDukal LLCMUI2026-01-12
30665973032659DukalDukal LLCMUI2026-01-12
30665973032666DukalDukal LLCMUI2026-01-12
30815112021406E-Z-GEL UltraSound GelBracco Diagnostics Inc.MUI2025-05-16
30815112021413E-Z-SCAN Low Viscosity UltraSound GelBracco Diagnostics Inc.MUI2025-05-16
30815112021420E-Z-SCAN Low Viscosity UltraSound GelBracco Diagnostics Inc.MUI2025-05-16
30815112021437E-Z-GEL UltraSound GelBracco Diagnostics Inc.MUI2025-05-16
20888277629841MEDLINEMEDLINE INDUSTRIES, INC.MUI2025-01-09
00850030915207RichmarSouth Dakota Partners Inc.MUI2023-08-02
10848340014854Asonic GelADVANCE MEDICAL DESIGNS, INC.MUI2023-06-13
40080196306238MedlineMEDLINE INDUSTRIES, INC.MUI2023-01-04
00810113688473ManaMed IncManamed, Inc.MUI2022-12-31
30193489025297MedlineMEDLINE INDUSTRIES, INC.MUI2022-12-02
40612479262117McKessonMCKESSON MEDICAL-SURGICAL INC.MUI2022-09-28
10855683006835MedVatPARKER LABORATORIES INCMUI2021-10-04
10035135013059MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MUI2021-02-24
10851809002040EcoVue HVHR PHARMACEUTICALS INC.MUI2020-09-21
10851809002361EcoVue HVHR PHARMACEUTICALS INC.MUI2020-09-21
20851809002375EcoVue HVHR PHARMACEUTICALS INC.MUI2020-09-21
M752HCT984915Stradis Medical, LLC.STRADIS MEDICAL LLCMUI2020-06-08
00812433020001Scrip HesscoScriphesscoMUI2019-10-16
10628108100254WavelengthNational Therapy Products IncMUI2019-06-04
10628108100261WavelengthNational Therapy Products IncMUI2019-06-04
00628108100271WavelengthNational Therapy Products IncMUI2019-06-04
10628108100285WavelengthNational Therapy Products IncMUI2019-06-04
10628108100308WavelengthNational Therapy Products IncMUI2019-06-04
10628108100315WavelengthNational Therapy Products IncMUI2019-06-04
10628108100322WavelengthNational Therapy Products IncMUI2019-06-04