FDA.reportPublic FDA data

MEDLINE

Primary DI
10653160368427
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
ECVC2205A
Catalog number
ECVC2205A
Device description
16CM 7F 3L CVC MAX BARRIER INSERTION
Published
2026-05-18
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
LROGeneral surgery tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213481000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213481000Medline General Surgery TrayMedline Industries, Inc.2022-05-24LRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00653160368420PackageGS15In Commercial Distribution
10653160368427PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160368420006531603684206531603684200653160368420
1065316036842710653160368427

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
025460908
Device count
1
Kit
true
Combination product
true
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
10197344144181MEDLINERTACIBDHPRTACIBDHP2026-08-07
10197344169429MEDLINEMSCSRG97310MSCSRG973102026-08-07
10197344169436MEDLINEMSCSRG97314MSCSRG973142026-08-07
10195327188955NAMICDYNJGWIRE20LDYNJGWIRE20L2022-08-04
10195327279776MedlineDNSC145169DNSC1451692023-06-13
10195327301057NAMICDYNJHWIRE100DYNJHWIRE1002023-01-29
10195327301590NAMICDYNJHWIRE101DYNJHWIRE1012023-01-29
10195327301606NAMICDYNJHWIRE102DYNJHWIRE1022023-01-29
10195327301613NAMICDYNJHWIRE103DYNJHWIRE1032023-01-29
10195327301620NAMICDYNJHWIRE104DYNJHWIRE1042023-01-29
10195327301637NAMICDYNJHWIRE105DYNJHWIRE1052023-01-29
10195327302153NAMICDYNJHWIRE106DYNJHWIRE1062023-01-29
10195327302184NAMICDYNJHWIRE107DYNJHWIRE1072023-01-29
10195327302191NAMICDYNJHWIRE108DYNJHWIRE1082023-01-29
10195327302207NAMICDYNJHWIRE109DYNJHWIRE1092023-01-29
10195327302214NAMICDYNJHWIRE110DYNJHWIRE1102023-01-29
10195327305987NAMICDYNJHWIRE111DYNJHWIRE1112023-01-29
10195327305994NAMICDYNJHWIRE112DYNJHWIRE1122023-01-29
10195327306007NAMICDYNJHWIRE113DYNJHWIRE1132023-01-29
10195327306014NAMICDYNJHWIRE114DYNJHWIRE1142023-05-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160529447HalyardAVID MEDICAL, INC.LRO2026-08-08
10809160529188HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529195HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529201HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529225HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529232HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529249HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529256HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529263HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529270HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529287HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529294HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529300HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529317HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529324HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529348HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529355HalyardAVID MEDICAL, INC.LRO2026-08-07
10885632529412SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-08-07
10885632529429SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-08-07
10885632529436SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-08-07
10809160528365HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528372HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528389HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528419HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528433HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528440HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528457HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528488HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528495HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528501HalyardAVID MEDICAL, INC.LRO2026-08-03