FDA.reportPublic FDA data

MEDLINE

Primary DI
10197344130252
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
CTR001201S
Catalog number
CTR001201S
Device description
GEL,ULTRASOUND,STRL,0.7-OZ,CLEAR,FOIL
Published
2026-04-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
K232957000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232957000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00197344130255PackageGS1100In Commercial Distribution
10197344130252PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197344130255001973441302551973441302550197344130255
1019734413025210197344130252

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry; Keep away from sunlight

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344130269MEDLINEMEDLINE INDUSTRIES, INC.MUI2026-01-23
00197344130279MEDLINEMEDLINE INDUSTRIES, INC.MUI2026-01-23
10665973032631DukalDukal LLCMUI2026-01-12
10665973032648DukalDukal LLCMUI2026-01-12
10665973032655DukalDukal LLCMUI2026-01-12
10665973032662DukalDukal LLCMUI2026-01-12
20665973032638DukalDukal LLCMUI2026-01-12
20665973032645DukalDukal LLCMUI2026-01-12
30665973032659DukalDukal LLCMUI2026-01-12
30665973032666DukalDukal LLCMUI2026-01-12
10815112021402E-Z-GEL UltraSound GelBracco Diagnostics Inc.MUI2025-05-16
10815112021419E-Z-SCAN Low Viscosity UltraSound GelBracco Diagnostics Inc.MUI2025-05-16
10815112021426E-Z-SCAN Low Viscosity UltraSound GelBracco Diagnostics Inc.MUI2025-05-16
10815112021433E-Z-GEL UltraSound GelBracco Diagnostics Inc.MUI2025-05-16
30815112021406E-Z-GEL UltraSound GelBracco Diagnostics Inc.MUI2025-05-16
30815112021413E-Z-SCAN Low Viscosity UltraSound GelBracco Diagnostics Inc.MUI2025-05-16
30815112021420E-Z-SCAN Low Viscosity UltraSound GelBracco Diagnostics Inc.MUI2025-05-16
30815112021437E-Z-GEL UltraSound GelBracco Diagnostics Inc.MUI2025-05-16
10197106849064CARDINAL HEALTHCardinal Health 200, LLCMUI2025-01-09
10888277629844MEDLINEMEDLINE INDUSTRIES, INC.MUI2025-01-09
20888277629841MEDLINEMEDLINE INDUSTRIES, INC.MUI2025-01-09
00850030915207RichmarSouth Dakota Partners Inc.MUI2023-08-02
00848340014857Asonic GelADVANCE MEDICAL DESIGNS, INC.MUI2023-06-13
10848340014854Asonic GelADVANCE MEDICAL DESIGNS, INC.MUI2023-06-13
10080196306237MedlineMEDLINE INDUSTRIES, INC.MUI2023-01-04
40080196306238MedlineMEDLINE INDUSTRIES, INC.MUI2023-01-04
00810113688473ManaMed IncManamed, Inc.MUI2022-12-31
10193489025293MedlineMEDLINE INDUSTRIES, INC.MUI2022-12-02
30193489025297MedlineMEDLINE INDUSTRIES, INC.MUI2022-12-02
20612479262106McKessonMCKESSON MEDICAL-SURGICAL INC.MUI2022-09-28