FDA.reportPublic FDA data

MEDLINE

Primary DI
10653160393702
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
DYNDV2783
Catalog number
DYNDV2783
Device description
PEDS IV START KIT
Published
2026-05-27
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
00653160393705PackageGS1100In Commercial Distribution
10653160393702PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160393705006531603937056531603937050653160393705
1065316039370210653160393702

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
10197344235391MEDLINEMPHEPREEMIEMPHEPREEMIE2026-10-13
10197344175987MEDLINEESS7044EPESS7044EP2026-07-13
10884389112090MEDLINEEQX7012EQX70122026-10-09
10197344175963MEDLINEESS7012EPESS7012EP2026-07-13
10884389931967MEDLINEMSC7366EPMSC7366EP2026-10-09
20193489079804MEDLINEBNS128632BNS1286322026-10-09
30193489079726MEDLINEBNS111718BNS1117182026-10-09
30193489079771MEDLINEBNS119386BNS1193862026-10-09
30193489079788MEDLINEBNS119387BNS1193872026-10-09
30193489079795MEDLINEBNS120988BNS1209882026-10-09
10197344104116MEDLINEPIVBCA18125PIVBCA181252025-02-06
10197344104130MEDLINEPIVBCA20100PIVBCA201002025-02-06
10197344104147MEDLINEPIVBCA20125PIVBCA201252025-02-06
20197344024992MedlineMPH22325HCGMPH22325HCG2024-03-11
10197344042388HUDSON RCIHUD1895HUD18952026-10-08
10197344042395HUDSON RCIHUD1896HUD18962026-10-08
10653160394273MEDLINEDYND71006DYND710062026-10-08
10653160394532MEDLINEDT22100ADT22100A2026-10-08
10653160394594MEDLINEDYNDC3490ADYNDC3490A2026-10-08
10653160394709MEDLINEDYNDC3601DYNDC36012026-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956562950CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-13
10198956593770CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-13
10198956597891CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-13
10198956599086CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-13
10198956599345CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-13
10198956604322CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-13
10653160395232CENTURIONCENTURION MEDICAL PRODUCTS CORPORATIONLRO2026-10-13
10809160540565HalyardAVID MEDICAL, INC.LRO2026-10-13
10809160540572HalyardAVID MEDICAL, INC.LRO2026-10-13
10809160540589HalyardAVID MEDICAL, INC.LRO2026-10-13
10809160540602HalyardAVID MEDICAL, INC.LRO2026-10-13
10885632540615SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-10-13
10198956331259CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956352230CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956399051CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956507425CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956508057CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956519701CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956523142CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956537491CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956540620CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956542716CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956546110CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956551015CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956553699CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956554689CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956555709CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956558335CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956566699CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956568143CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12