FDA.reportPublic FDA data

EcoVue

Primary DI
20851809002832
Brand
EcoVue
Company
HR PHARMACEUTICALS INC.
Model
283
Catalog number
283
Device description
Non-Sterile Ultrasound Gel, FlexPac
Published
2018-07-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MUIMedia, coupling, ultrasound

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUIMedia, Coupling, UltrasoundRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851809002835PackageGS1100In Commercial Distribution
20851809002832PackageGS14In Commercial Distribution
00851809002838PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085180900283510851809002835
2085180900283220851809002832
00851809002838008518090028388518090028380851809002838

GMDN Terms#

Term, Definition table
TermDefinition
Coupling gel, non-sterileA non-sterile medium designed to be applied to a patient's unbroken skin surface to provide a coupling between an analytical device (e.g., ultrasound transducer, optical glucose monitoring system) and the patient, allowing for the emission and reception of signals (e.g., ultrasound, light) that pass through the skin during an examination. It is in the form of a non-sticky, fluid-like gel that may also assists the operator's ability to move the analytical device smoothly over the skin to better analyse the site of interest. It may be used by a healthcare professional or layperson. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight32Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(717)252-1110chris.wiesman@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 DI, Brand, Model table
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197344130279MEDLINEMEDLINE INDUSTRIES, INC.MUI2026-01-23
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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
30851809002020EcoVue HVHR PHARMACEUTICALS INC.MUI2020-09-21
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