FDA.reportPublic FDA data

MEDLINE

Primary DI
10653160395881
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
ECVC2770A
Catalog number
ECVC2770A
Device description
7FR 16 CM TRIPLE LUMEN CVC INSERTION KIT
Published
2026-10-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
00653160395884PackageGS15In Commercial Distribution
10653160395881PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160395884006531603958846531603958840653160395884
1065316039588110653160395881

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
true
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10193489006728MEDLINEURO12575URO125752026-10-23
10197344219261MEDLINEDYNDSCL1500RDYNDSCL1500R2026-10-23
10653160395461MEDLINEDYNDC3514BDYNDC3514B2026-10-24
10653160395713MEDLINEEBSI1586BEBSI1586B2026-10-24
10653160395720MEDLINEDYNDC3637DYNDC36372026-10-24
10653160395751MEDLINEECVC8657ECVC86572026-10-24
10653160395782MEDLINEEBSI1426BEBSI1426B2026-10-24
10653160395799MEDLINEECVC2440CECVC2440C2026-10-24
10653160395805MEDLINEEBSI1687AEBSI1687A2026-10-24
10653160395812MEDLINEEBSI1356AEBSI1356A2026-10-24
10653160395850MEDLINEECVC7295AECVC7295A2026-10-24
10653160395867MEDLINEEBSI1590AEBSI1590A2026-10-24
10653160395911MEDLINEEBSI1529AEBSI1529A2026-10-24
10653160395959MEDLINEDYNDV2823DYNDV28232026-10-24
00197344133850MEDLINEFRES2502FRES25022026-06-09
00197344133874MEDLINEFRES2503FRES25032026-06-09
00197344133898MEDLINEFRES2504FRES25042026-06-09
10884389194775MEDLINEMDS9911MDS99112016-10-14
10884389194799MEDLINEMDS9911MQMDS9911MQ2016-10-14
00197344098111MEDLINEMG7583MG75832024-08-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10653160395744CENTURIONCENTURION MEDICAL PRODUCTS CORPORATIONLRO2026-10-24
10653160395751MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-24
10653160395799MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-24
10653160395850MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-24
10653160395867MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-24
10653160395959MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-24
10198956433113CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956460942CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956544123CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956556065CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956557055CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956557642CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956562745CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956571129CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956577565CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956577589CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956578890CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956578951CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956579118CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956583863CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956584709CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956585591CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956586727CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956586956CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956590939CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956591776CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956595781CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956601079CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956602182CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956602458CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23