FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10193489075670
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
651202927
Catalog number
651202927
Device description
AURORA ST LUKES MEDICAL CENTER
Published
2021-11-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
40193489075671PackageGS140In Commercial Distribution
10193489075670PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019348907567140193489075671
1019348907567010193489075670

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
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10888277419452MEDLINEMDTZ1068516ABMDTZ1068516AB2016-10-14
00888277719081RexallDG11009803DG110098032026-06-03
10884389106303MEDLINEDYND20323DYND203232021-01-05
10888277656970MEDLINEDYND50221NSDYND50221NS2021-01-02
10888277656987MEDLINEDYND50223NSDYND50223NS2021-01-02
10888277657007MEDLINEDYND50252NSDYND50252NS2021-01-02
10888277658325MEDLINEOR712NSOR712NS2021-01-02
10888277694507MEDLINEDYND50251NSDYND50251NS2021-01-02
10888277694514MEDLINEDYND50253NS1DYND50253NS12021-01-02
10888277725157MEDLINEEQX2377EQX23772023-12-15
10080196000630Teleflex/Hudson RCI540254022016-04-08
10080196003648Teleflex/Hudson RCI2700-2052700-2052016-04-08
10080196986217Teleflex/Hudson RCI540354032016-04-08
10193489078022NAMICH74904487202H749044872022022-02-24
10812564036022MedlineSYN3000SYN30002026-03-11
10812564036077MedlineSYN3004SYN30042026-03-11
10812564036107MedlineSYN3015SYN30152026-03-11
10812564036183MedlineSYN3020SYN30202026-03-11
10812564036190MedlineSYN3025SYN30252026-03-11
10812564036213MedlineSYN3030SYN30302026-03-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160522639HalyardAVID MEDICAL, INC.OES2026-06-04
10198956459960CARDINAL HEALTHCardinal Health 200, LLCOES2026-06-03
10198956490734CARDINAL HEALTHCardinal Health 200, LLCOES2026-06-01
10198956492325CARDINAL HEALTHCardinal Health 200, LLCOES2026-06-01
10198956494206CARDINAL HEALTHCardinal Health 200, LLCOES2026-06-01
10080196726707Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2024-12-22
10193489016390Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-12-21
10193489067231Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-12-21
10193489439298Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-07-29
10193489455601Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-13
10193489409987Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-08
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10193489421699Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-08
10193489421910Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-08
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10193489425413Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-08
10193489425871Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-08
10193489426168Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-08
10193489426182Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-08
10193489426502Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-08
10193489427752Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-08
10193489428865Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-08