FDA.reportPublic FDA data

EcoVue

Primary DI
10851809002828
Brand
EcoVue
Company
HR PHARMACEUTICALS INC.
Model
282
Catalog number
282
Device description
Sterile Ultrasound Gel, Safewrap
Published
2018-07-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
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
10851809002828PackageGS148In Commercial Distribution
20851809002825PackageGS16In Commercial Distribution
30851809002822PackageGS1100In Commercial Distribution
40851809002829PackageGS14In Commercial Distribution
50851809002826PackageGS1525In Commercial Distribution
00851809002821PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085180900282810851809002828
2085180900282520851809002825
3085180900282230851809002822
4085180900282940851809002829
5085180900282650851809002826
00851809002821008518090028218518090028210851809002821

GMDN Terms#

Term, Definition table
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#

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
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(717)252-1110rdohm@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
true

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
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
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