FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10198459075285
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ82971A
Catalog number
DYNJ82971A
Device description
LEFT HEART CATH PK W MFLD
Published
2024-08-04
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
OESCardiac catheterization kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OESCardiac Catheterization KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40198459075286PackageGS13In Commercial Distribution
10198459075285PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019845907528640198459075286
1019845907528510198459075285

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, 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)633-5463customerservice@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10197344216123MEDLINESSBCS21GLSSBCS21GL2026-07-24
10197344219575MEDLINEMDS99905MDS999052026-07-24
10653160391326MEDLINEEBSI1865EBSI18652026-07-24
30193489017742MEDLINE6651CBL22X16651CBL22X12026-07-24
30193489017759MEDLINE6651CBL22X26651CBL22X22026-07-24
30193489017766MEDLINE6651CBL22X36651CBL22X32026-07-24
30193489017773MEDLINE6651CBL22X46651CBL22X42026-07-24
30193489017780MEDLINE6651CBL34X36651CBL34X32026-07-24
30193489017797MEDLINE6651CBL34X46651CBL34X42026-07-24
30193489104893MEDLINEMDT011201XLMDT011201XL2026-07-24
40193489107969MEDLINEMDTISO3AHCAR3MDTISO3AHCAR32026-07-24
40193489120241MEDLINEMDTISO3AHGMDTISO3AHG2026-07-24
40193489120258MEDLINEMDTISO3AHG3XLMDTISO3AHG3XL2026-07-24
50080196247576MEDLINEMDT011205MDT0112052026-07-24
50193489109885MEDLINEMDTISO3AHY3XLMDTISO3AHY3XL2026-07-24
50193489109892MEDLINEMDTISO3AHYCARMDTISO3AHYCAR2026-07-24
10193489987522MEDLINEURO175814TURO175814T2022-05-22
10193489987546MEDLINEURO175818TURO175818T2022-05-22
10193489988505MEDLINEURO175816TURO175816T2022-05-22
00080196311661MEDLINENON241278NON2412782026-07-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160527672HalyardAVID MEDICAL, INC.OES2026-07-21
10198956528062CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-20
10809160527580HalyardAVID MEDICAL, INC.OES2026-07-20
10809160527436HalyardAVID MEDICAL, INC.OES2026-07-17
10198956335523CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-16
10198956509283CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-16
10198956524880CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-16
10198956529083CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-16
10198956529410CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-16
10809160527252HalyardAVID MEDICAL, INC.OES2026-07-16
10198956478107CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-09
10198956518131CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-09
10198956526983CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-09
10198956528208CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-09
10809160526859HalyardAVID MEDICAL, INC.OES2026-07-08
10198956463400CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-06
10198956525993CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-06
10809160526361HalyardAVID MEDICAL, INC.OES2026-06-26
10809160526262HalyardAVID MEDICAL, INC.OES2026-06-25
10809160525937HalyardAVID MEDICAL, INC.OES2026-06-24
10809160525968HalyardAVID MEDICAL, INC.OES2026-06-24
10809160526019HalyardAVID MEDICAL, INC.OES2026-06-24
10809160526132HalyardAVID MEDICAL, INC.OES2026-06-24
10198956415553CARDINAL HEALTHCardinal Health 200, LLCOES2026-06-23
10809160525869HalyardAVID MEDICAL, INC.OES2026-06-23
10809160525890HALYARDAVID MEDICAL, INC.OES2026-06-23
10809160525234HalyardAVID MEDICAL, INC.OES2026-06-22
10809160525555HalyardAVID MEDICAL, INC.OES2026-06-22
10809160525579HalyardAVID MEDICAL, INC.OES2026-06-22
10809160523148HalyardAVID MEDICAL, INC.OES2026-06-09