FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10653160392965
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNDC2969A
Device description
DIALYSIS ON/OFF TRAY
Published
2026-04-01
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

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
10653160392965PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1065316039296510653160392965

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.

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
10080196320417MEDLINEMDS30102MDS301022026-09-09
10080196320424MEDLINEMDS30103MDS301032026-09-09
10080196320431MEDLINEMDS30104MDS301042026-09-09
10080196320509MEDLINEMDS30202MDS302022026-09-09
10080196320523MEDLINEMDS30204MDS302042026-09-09
10080196320530MEDLINEMDS30205MDS302052026-09-09
10080196320660MEDLINEMDS30301MDS303012026-09-09
10080196320721MEDLINEMDS30302MDS303022026-09-09
10080196320752MEDLINEMDS30303MDS303032026-09-09
10080196320790MEDLINEMDS30304MDS303042026-09-09
10080196320806MEDLINEMDS30305MDS303052026-09-09
10080196321179MEDLINEMDS30405MDS304052026-09-09
10080196321384MEDLINEMDS30603MDS306032026-09-14
10197344220083MEDLINEDYNJP2530TWLDYNJP2530TWL2026-09-18
10197344220090MEDLINEDYNJP2540TWLDYNJP2540TWL2026-09-18
10888277198739MEDLINEMDT821231QMDT821231Q2026-09-18
10888277688896MEDLINEMDS30106BMDS30106B2026-09-18
10888277688902MEDLINEMDS30107BMDS30107B2026-09-18
10888277688919MEDLINEMDS30108BMDS30108B2026-09-18
10888277688926MEDLINEMDS30109BMDS30109B2026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160537855HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537862HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537879HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537886HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537893HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537909HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537916HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537923HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537930HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537947HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537954HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537961HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537985HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537992HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160538005HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160538029HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160538036HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160538043HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537541HalyardAVID MEDICAL, INC.LRO2026-09-19
10809160537558HalyardAVID MEDICAL, INC.LRO2026-09-19
10809160537572HalyardAVID MEDICAL, INC.LRO2026-09-19
10809160537589HalyardAVID MEDICAL, INC.LRO2026-09-19
10809160537596HalyardAVID MEDICAL, INC.LRO2026-09-19
10809160537602HalyardAVID MEDICAL, INC.LRO2026-09-19
10809160537640HalyardAVID MEDICAL, INC.LRO2026-09-19
10809160537664HalyardAVID MEDICAL, INC.LRO2026-09-19
10809160537688HalyardAVID MEDICAL, INC.LRO2026-09-19
10809160537695HalyardAVID MEDICAL, INC.LRO2026-09-19
10809160537701HalyardAVID MEDICAL, INC.LRO2026-09-19
10809160537732HalyardAVID MEDICAL, INC.LRO2026-09-19