FDA.reportPublic FDA data

EcoVue

Primary DI
20851809002801
Brand
EcoVue
Company
HR PHARMACEUTICALS INC.
Model
280
Catalog number
280
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
10851809002804PackageGS148In Commercial Distribution
20851809002801PackageGS16In Commercial Distribution
30851809002808PackageGS1100In Commercial Distribution
40851809002805PackageGS14In Commercial Distribution
50851809002802PackageGS1525In Commercial Distribution
00851809002807PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085180900280410851809002804
2085180900280120851809002801
3085180900280830851809002808
4085180900280540851809002805
5085180900280250851809002802
00851809002807008518090028078518090028070851809002807

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
Weight20Gram

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
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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

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