FDA.report

EcoVue

Primary DI
10851809002811
Brand
EcoVue
Company
HR PHARMACEUTICALS INC.
Model
281
Catalog number
281
Device description
Non-Sterile Ultrasound Gel, Packet
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

Related Records

Contact Domains

Product Codes

CodeName
MUIMedia, coupling, ultrasound

Product Code Classifications

CodeDeviceSpecialtyClass
MUIMedia, Coupling, UltrasoundRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10851809002811PackageGS1100In Commercial Distribution
20851809002818PackageGS14In Commercial Distribution
00851809002814PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1085180900281110851809002811
2085180900281820851809002818
00851809002814008518090028148518090028140851809002814

GMDN Terms

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

TypeValueUnit
Weight20Gram

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

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

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