FDA.report

MEDLINE

Primary DI
00197344130279
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
CTR001201SW
Catalog number
CTR001201SW
Device description
GEL,ULTRASOUND,STRL,0.7-OZ,CLEAR,OVRWRAP
Published
2026-01-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
MUIMedia, coupling, ultrasound

Product Code Classifications

CodeDeviceSpecialtyClass
MUIMedia, Coupling, UltrasoundRadiology2

Premarket Submissions

SubmissionSupplement
K232957000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K232957000Sterile and Non-Sterile Ultrasound GelsJianerkang Medical Co., Ltd.2023-12-15MUI

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00197344130279PackageGS1100In Commercial Distribution
10197344130269PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00197344130279001973441302791973441302790197344130279
1019734413026910197344130269

GMDN Terms

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, transcutaneous electrical stimulator) and the patient, allowing for the emission and reception of energy/signals (e.g., electrical current, light) that pass through the skin during an examination or treatment. 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.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry; Keep away from sunlight.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags

DUNS number
025460908
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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