FDA.reportPublic FDA data

CLINICAL HEALTH SERVICES, INC.

Primary DI
00815290013889
Brand
CLINICAL HEALTH SERVICES, INC.
Company
CLINICAL HEALTH SERVICES, INC.
Model
CLIH503X-BLUE
Catalog number
CLIH503X-BLUE
Device description
Ultrasound Gel, BLUE, 5Liter with Dispenser
Published
2016-12-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012522000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012522000WAVELENGTH MULTI-PURPOSE ULTRASOUND GELNational Therapy Products, Inc.2001-10-18ITX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815290015005PackageGS14In Commercial Distribution
00815290013889PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815290015005008152900150058152900150050815290015005
00815290013889008152900138898152900138890815290013889

GMDN Terms#

Term, Definition table
TermDefinition
Skin topical coupling gelA medium designed to be applied to a patient's unbroken skin surface (excludes the eye surface) to provide a coupling between an analytical or therapeutic device (e.g., ultrasound transducer, optical glucose monitoring system,) and the patient, allowing for the emission and reception of energy/signals (e.g., electrical current, light, blood gas) that pass through the skin during an examination or treatment. Also known as contact gel, it is in the form of a fluid-like gel that may also assist in moving the parent device smoothly over the skin. It may be used by a healthcare professional in a clinical setting and layperson in the home. After application, this device cannot be reused.

Contacts#

Phone, Email table
PhoneEmail
813-871-3120jeff@clinicalhealthservices.com

Regulatory Flags#

DUNS number
004416769
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815290018686Therapist's ChoiceTC5050-TC OTCTC5050-TC2026-06-30
00860015112446Doctor's Choice®Doctor's Choice® TENS 3MTDoctor's Choice® TENS 3MT2026-07-14
00815290018310Therapist’s Choice® TENS 2N1TENS 2N1TENS 2N12021-10-28
00815290017719Therapist’s Choice® TENS 7500TENS 7500Digital TENS2021-02-10
00815290013896CLINICAL HEALTH SERVICES, INC.CLIC503X-ClearCLIC503X-Clear2016-12-07
00815290013872CLINICAL HEALTH SERVICES, INC.CLID373X-LotionCLID373X-Lotion2016-12-09
00860015112408TENSnet 3MTTENSnet 3MTTENSnet 3MT2025-12-05
10860015112405TENSnet 3MTTENSnet 3MTTENSnet 3MT2025-12-05
00815290017276Therapist’s Choice® TENS 3N1RBTENS 3N1RBTENS 3MT2020-07-06
00815290018303Therapist’s Choice® TENS 12MT Small Carrying CaseTENS 12MT Small Carrying CaseTENS 12MT2024-12-21
10815290018300Therapist’s Choice® TENS 12MT Small Carrying CaseTENS 12MT Small Carrying CaseTENS 12MT2024-12-21
00815290019409ePower® T1 TENS UNITT1 TENS UNITT1 TENS UNIT2023-09-17
00815290019416ePower® T2 DIGITAL TENST2 DIGITAL TENST2 DIGITAL TENS2023-09-17
00815290019423ePower® TE2 COMBO TENS & EMSePower® TE2 COMBO TENS & EMSePower® TE2 COMBO TENS & EMS2023-09-17
10815290019406ePower® T1 TENS UNITT1 TENS UNITT1 TENS UNIT2023-09-17
10815290019413ePower® T2 DIGITAL TENST2 DIGITAL TENST2 DIGITAL TENS2023-09-17
10815290019420ePower® TE2 COMBO TENS & EMSePower® TE2 COMBO TENS & EMSePower® TE2 COMBO TENS & EMS2023-09-17
00815290019232ePower®ePower® E1 EMS UNITePower® E1 EMS UNIT2023-07-15
00815290019249ePower®ePower® E2 DIGITAL EMSePower® E2 DIGITAL EMS2023-07-15
10815290019239ePower®ePower® E1 EMS UNITePower® E1 EMS UNIT2023-07-15

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Primary DI, Brand, Company table
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10841436125311CIV-Clear™ Transducer CoverCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
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