FDA.reportPublic FDA data

MEDLINE

Primary DI
10653160395768
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
CVI5130B
Catalog number
CVI5130B
Device description
PORT ACCESS KIT
Published
2026-10-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
00653160395761PackageGS124In Commercial Distribution
10653160395768PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160395761006531603957616531603957610653160395761
1065316039576810653160395768

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
00197344205281CURADCUR47451RBCUR47451RB2026-10-29
00884389108362CURADCUR4025RCUR4025R2026-10-29
00884389108393CURADCUR4135RCUR4135R2026-10-29
00888277187088CURADCUR4125RCUR4125R2026-10-29
10197344148608MEDLINERTDCIVDHGRTDCIVDHG2026-10-29
10197344148615MEDLINERTDCIVDHNRTDCIVDHN2026-10-29
10197344148622MEDLINERTDCIVDHPRTDCIVDHP2026-10-29
10197344148639MEDLINERTDCIVDHRRTDCIVDHR2026-10-29
10197344148646MEDLINERTDCIVDHYRTDCIVDHY2026-10-29
10197344148653MEDLINERTDCIVDHZRTDCIVDHZ2026-10-29
10197344219278MEDLINEDYNDSCL3000RDYNDSCL3000R2026-10-29
10197344223862MEDLINEDYSNR24OVCOLDDYSNR24OVCOLD2026-10-29
10653160395690MEDLINEDYNDC3636DYNDC36362026-10-29
10653160395874MEDLINEEBSI1161BEBSI1161B2026-10-29
10653160395935MEDLINEDYNDH2410DYNDH24102026-10-29
10653160395966MEDLINEEBSI1729BEBSI1729B2026-10-29
10653160396017MEDLINEEBSI1427BEBSI1427B2026-10-29
10653160396024MEDLINEDYNDC3648DYNDC36482026-10-29
10653160396031MEDLINEEBSI1840AEBSI1840A2026-10-29
20197344223388MEDLINEL2USAXLFL2USAXLF2026-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956323209CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956496101CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956531932CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956546035CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956548817CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956561335CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956575264CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956575905CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956577251CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956577657CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956584440CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956586161CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956586338CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956589179CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956589650CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956591080CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956591868CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956593213CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956595460CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956596221CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956598744CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956600102CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956603059CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956605046CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956607118CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956607125CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956607958CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956608528CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956609815CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29
10198956609990CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-29