FDA.reportPublic FDA data

N/A

Primary DI
80092237613258
Brand
N/A
Company
COMPASS HEALTH BRANDS CORP.
Model
LS5288
Device description
TheraSonic Conductive Gel, 8-o
Published
2016-10-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
80092237613258PackageGS124In Commercial Distribution
00092237613252PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
8009223761325880092237613258
00092237613252000922376132520922376132520092237613252

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
440-572-1962CustomerService@compasshealthbrands.com
800-376-7263customerservice@compasshealthbrands.com

Regulatory Flags#

DUNS number
827221698
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
00092237613269Roscoe MedicalLS52662016-10-13
00194346678921Equate73085EQ2026-03-09
00714905117649Fab StimDT30252026-02-06
00714905710024Fab StimDT70252026-02-06
00860163000312CMS DT30292026-02-06
00092237622209SCRIPHESSCO672-0192-CH2026-02-03
00092237622216SCRIPHESSCO672-0193-CH2026-02-03
00092237622339SCRIPHESSCO672-0195-CH2026-02-03
30194346615156Equate 72085EQ2026-01-20
00092237627495Roscoe MedicalO2C6P2026-01-15
00023601130402CarexFGB30400 00002025-12-01
00092237622193SCRIPHESSCO672-0010-CH2025-11-24
00714905710062FabStimE1P3000TC2FS2025-11-18
00092237621967TwinStimDS5002-OTC2025-09-29
00092237902257MicroBlock Antimicrobial Electrode400-877-MIC2020-06-11
00092237902240MicroBlock Antimicrobial Electrode400-872-MIC2019-01-08
00092237902288MicroBlock Antimicrobial Electrode400-852-MIC2020-06-11
00092237902264MicroBlock Antimicrobial Electrode400-879-MIC2020-06-11
00092237902271MicroBlock Antimicrobial Electrode400-881-MIC2020-06-11
00092237611531Roscoe MedicalLS52552016-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974405095104CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.ITX2026-05-26
06974405095159CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.ITX2026-05-26
06974405095166CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.ITX2026-05-26
00841517112561Sonosite PXFUJIFILM SONOSITE, INC.ITX2026-03-12
16975424198729Proficient SurgicalEXACT MEDICAL MANUFACTURING, INC.ITX2026-03-11
04987670102721PHASED ARRAY TRANSDUCERCANON INC.ITX2026-03-01
04987670102745LINEAR ARRAY TRANSDUCERCANON INC.ITX2026-03-01
04987670102752LINEAR ARRAY TRANSDUCERCANON INC.ITX2026-03-01
04987670102769PHASED ARRAY TRANSDUCERCANON INC.ITX2026-03-01
04987670102783LINEAR ARRAY TRANSDUCERCANON INC.ITX2026-03-01
04987670102806CW DOPPLER PENCIL TRANSDUCERCANON INC.ITX2026-03-01
04987670102820CONVEX ARRAY TRANSDUCERCANON INC.ITX2026-03-01
04987670102837ENDOCAVITARY TRANSDUCERCANON INC.ITX2026-03-01
04987670102844LINEAR ARRAY TRANSDUCERCANON INC.ITX2026-03-01
04987670102851ENDOCAVITARY TRANSDUCERCANON INC.ITX2026-03-01
04987670102868ENDOCAVITARY TRANSDUCERCANON INC.ITX2026-03-01
04987670102875CONVEX ARRAY TRANSDUCERCANON INC.ITX2026-03-01
04987670102882CONVEX ARRAY TRANSDUCERCANON INC.ITX2026-03-01
04987670106507DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-03-01
04987670106514DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-03-01
04987670106521DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-03-01
10885632426711HALYARDOWENS & MINOR DISTRIBUTION, INC.ITX2026-02-11
10885632426728HALYARDOWENS & MINOR DISTRIBUTION, INC.ITX2026-02-11
10885632426735HALYARDOWENS & MINOR DISTRIBUTION, INC.ITX2026-02-11
10885632426742HALYARDOWENS & MINOR DISTRIBUTION, INC.ITX2026-02-11
10885632426759HALYARDOWENS & MINOR DISTRIBUTION, INC.ITX2026-02-11
10885632426766HALYARDOWENS & MINOR DISTRIBUTION, INC.ITX2026-02-11
10885632426773HALYARDOWENS & MINOR DISTRIBUTION, INC.ITX2026-02-11
10885632426780HALYARDOWENS & MINOR DISTRIBUTION, INC.ITX2026-02-11
10885632426797HALYARDOWENS & MINOR DISTRIBUTION, INC.ITX2026-02-11