FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10193489747621
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ0545064X
Catalog number
DYNJ0545064X
Device description
CATH LAB ANGIO PACK-LF
Published
2021-01-31
Public version status
Update
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
OEQAngiography/angioplasty kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEQAngiography/Angioplasty KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40193489747622PackageGS15In Commercial Distribution
10193489747621PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019348974762240193489747622
1019348974762110193489747621

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

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
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160393900MEDLINEBSIPIV1023BSIPIV10232026-10-01
10888277664395MEDLINEMPHUA120MPMPHUA120MP2026-10-01
20080196181893GeminiGEM1148SGEM1148S2016-10-14
20080196181954GeminiGEM2112SGEM2112S2016-10-14
20080196187307GeminiGEM5172SGEM5172S2016-10-14
20080196921208GeminiGEM2112GEM21122016-10-14
20888277655499MEDLINEMLABTP12GENMLABTP12GEN2026-10-01
10193489011265GeminiGEMTITAN54TGEMTITAN54T2021-05-26
10197344149018GeminiGEMTITAN18TCGEMTITAN18TC2025-08-14
10884389112076MEDLINE INDUSTRIES, INC.EQX7022EQX70222021-05-18
10884389121740MEDLINE INDUSTRIES, INC.EQX7044EQX70442021-05-18
10884389931950MEDLINE INDUSTRIES, INC.MSC7348EPMSC7348EP2021-05-18
20080196181152GeminiGEM1124SGEM1124S2016-10-14
20080196181367GeminiGEM1130SGEM1130S2016-10-14
20080196181428GeminiGEM1136SGEM1136S2016-10-14
20080196181565GeminiGEM1140SGEM1140S2016-10-14
20080196921130GeminiGEM1124GEM11242016-10-14
20080196921178GeminiGEM1145GEM11452016-10-14
20197344695314GeminiGEM5172SCGEM5172SC2024-07-15
20197344695321GeminiGEM5172TCGEM5172TC2024-07-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956509702CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956551589CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956553583CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956581593CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956581661CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956588820CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956592575CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956592681CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956596597CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956596696CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
10198956598188CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-30
00884450436004Merit Medical®Merit Medical Systems, Inc.OEQ2026-09-29
10198956540491CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-29
10198956542136CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-29
10198956580770CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-29
10198956580978CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-29
10198956589988CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-29
10198956590625CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-29
10198956590953CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-29
B098AMS194890Aligned Medical SolutionsAligned Medical SolutionsOEQ2026-09-29
10809160539132HALYARDAVID MEDICAL, INC.OEQ2026-09-28
10198956439849CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956512177CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956545991CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956551657CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956556454CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956567948CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956579316CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956581838CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25
10198956582293CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-09-25