FDA.reportPublic FDA data

Medline

Primary DI
10080196306237
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
MDS092010C
Catalog number
MDS092010C
Device description
GEL,ULTRASOUND,5-LITER JUG,CLEAR
Published
2023-01-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
40080196306238PackageGS14In Commercial Distribution
10080196306237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4008019630623840080196306238
1008019630623710080196306237

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
Special Storage Condition, Specify00Keep 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
10884389106303MEDLINEDYND20323DYND203232021-01-05
10888277656970MEDLINEDYND50221NSDYND50221NS2021-01-02
10888277656987MEDLINEDYND50223NSDYND50223NS2021-01-02
10888277657007MEDLINEDYND50252NSDYND50252NS2021-01-02
10888277658325MEDLINEOR712NSOR712NS2021-01-02
10888277694507MEDLINEDYND50251NSDYND50251NS2021-01-02
10888277694514MEDLINEDYND50253NS1DYND50253NS12021-01-02
10888277725157MEDLINEEQX2377EQX23772023-12-15
10080196000630Teleflex/Hudson RCI540254022016-04-08
10080196003648Teleflex/Hudson RCI2700-2052700-2052016-04-08
10080196986217Teleflex/Hudson RCI540354032016-04-08
10193489078022NAMICH74904487202H749044872022022-02-24
10812564036022MedlineSYN3000SYN30002026-03-11
10812564036077MedlineSYN3004SYN30042026-03-11
10812564036107MedlineSYN3015SYN30152026-03-11
10812564036183MedlineSYN3020SYN30202026-03-11
10812564036190MedlineSYN3025SYN30252026-03-11
10812564036213MedlineSYN3030SYN30302026-03-11
10812564036381MedlineSYN3872SYN38722026-03-11
10884389001677Teleflex/Hudson RCI540154012016-04-08

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
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
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