FDA.reportPublic FDA data

MEDLINE

Primary DI
10888277629844
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
CTR001201
Catalog number
CTR001201
Device description
GEL,ULTRASOUND,NON-STERILE,0.7-OZ,CLEAR
Published
2025-01-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K101952000
K232957000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101952000KONIX ULTRASOUND GELTurkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa2011-05-27ITX
K232957000Sterile and Non-Sterile Ultrasound GelsJianerkang Medical Co., Ltd.2023-12-15MUI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888277629841PackageGS1100In Commercial Distribution
10888277629844PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088827762984120888277629841
1088827762984410888277629844

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 away from sunlight. Keep dry

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
10080196158652MEDLINE INDUSTRIES, INC.MDS139000MDS1390002026-07-16
10884389101551MEDLINEMDS160684MDS1606842016-10-14
10884389101575MEDLINEMDS160860MDS1608602016-10-14
10884389101674MEDLINEMDS160820MDS1608202016-10-14
10884389101704MEDLINEMDS160828MDS1608282016-10-14
10884389101728MEDLINEMDS160628MDS1606282016-10-14
10884389191613MEDLINEMDS160604MDS1606042016-10-14
10080196456765MEDLINEVDYND20302VDYND203022026-07-14
10080196031764MEDLINEDYND20125DYND201252026-07-13
10197344175963MEDLINEESS7012EPESS7012EP2026-07-13
10197344175970MEDLINEESS7022EPESS7022EP2026-07-13
10197344175987MEDLINEESS7044EPESS7044EP2026-07-13
10197344176007MEDLINEESS9022EPESS9022EP2026-07-13
10197344176014MEDLINEESS9045EPESS9045EP2026-07-13
10197344176021MEDLINEESS9048EPESS9048EP2026-07-13
10197344176038MEDLINEESS9066EPESS9066EP2026-07-13
10197344214723MEDLINEHCSLADYBUGSOLHCSLADYBUGSOL2026-07-13
20193489108214MEDLINEMDTZ1017073CAMDTZ1017073CA2026-07-13
20197344219435MEDLINEMDT2168056XGVMDT2168056XGV2026-07-13
20888277636559MEDLINEMDTZ1017073ABMDTZ1017073AB2026-07-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344130252MEDLINEMEDLINE INDUSTRIES, INC.MUI2026-04-09
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
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