FDA.reportPublic FDA data

CLINICAL HEALTH SERVICES, INC.

Primary DI
00815290013872
Brand
CLINICAL HEALTH SERVICES, INC.
Company
CLINICAL HEALTH SERVICES, INC.
Model
CLID373X-Lotion
Catalog number
CLID373X-Lotion
Device description
Ultrasound Lotion, Gallon 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
MUIMedia,Coupling,Ultrasound

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUIMedia, Coupling, UltrasoundRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K013212000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K013212000WAVELENGHT ULTRASOUND LOTIONNational Therapy Products, Inc.2002-02-25MUI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815290015012PackageGS14In Commercial Distribution
00815290013872PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815290015012008152900150128152900150120815290015012
00815290013872008152900138728152900138720815290013872

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
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
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00815290013889CLINICAL HEALTH SERVICES, INC.CLIH503X-BLUECLIH503X-BLUE2016-12-09
00815290013896CLINICAL HEALTH SERVICES, INC.CLIC503X-ClearCLIC503X-Clear2016-12-07
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
10815290019246ePower®ePower® E2 DIGITAL EMSePower® E2 DIGITAL EMS2023-07-15
00815290016361Therapist’s Choice® TENS 3MTTENS 3MTTENS 3MT2019-01-29
00815290016552Therapist’s Choice® EMS 250EMS 250EMS 2502019-08-02

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