FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
40193489931588
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ46361K
Catalog number
DYNJ46361K
Device description
CARDIAC CATH PACK
Published
2021-09-01
Public version status
Update
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
OESCardiac catheterization kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OESCardiac Catheterization KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40193489931588PackageGS14In Commercial Distribution
10193489931587PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019348993158840193489931588
1019348993158710193489931587

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463customerservice@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
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
false
Sterilization required before use
false

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
10809160539545HalyardAVID MEDICAL, INC.OES2026-10-01
10198956488847CARDINAL HEALTHCardinal Health 200, LLCOES2026-09-30
10198956516946CARDINAL HEALTHCardinal Health 200, LLCOES2026-09-30
10198956592308CARDINAL HEALTHCardinal Health 200, LLCOES2026-09-30
10198956593459CARDINAL HEALTHCardinal Health 200, LLCOES2026-09-30
10198956596641CARDINAL HEALTHCardinal Health 200, LLCOES2026-09-30
10809160539477HalyardAVID MEDICAL, INC.OES2026-09-30
10198956461963CARDINAL HEALTHCardinal Health 200, LLCOES2026-09-29
10809160539262HalyardAVID MEDICAL, INC.OES2026-09-29
B098AMS194460Aligned Medical SolutionsAligned Medical SolutionsOES2026-09-28
B098DDS1159D0Aligned Medical SolutionsAligned Medical SolutionsOES2026-09-26
10198459754210MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459754524MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459755699MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459755705MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459758287MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459758294MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459759291MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459761850MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459766336MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459771224MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459774126MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459775437MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459775666MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459775673MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459775680MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459778827MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459779985MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459784996MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459786808MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25