FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
40195327157938
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
SAMPC0683
Catalog number
SAMPC0683
Device description
TEST KIT FOR DYNJGWIRE01
Published
2022-05-15
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
DQXWire, guide, catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQXWire, Guide, CatheterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40195327157938PackageGS150In Commercial Distribution
10195327157937PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019532715793840195327157938
1019532715793710195327157937

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10816349013536GuideRightLake Region MedicalDQX2026-03-24
10816349013543GuideRightLake Region MedicalDQX2026-03-24
10816349013550GuideRightLake Region MedicalDQX2026-03-24
10816349013567GuideRightLake Region MedicalDQX2026-03-24
10816349013574GuideRightLake Region MedicalDQX2026-03-24
10816349013581GuideRightLake Region MedicalDQX2026-03-24
10816349013598GuideRightLake Region MedicalDQX2026-03-24
10816349013604GuideRightLake Region MedicalDQX2026-03-24
10816349013611GuideRightLake Region MedicalDQX2026-03-24
10816349013628GuideRightLake Region MedicalDQX2026-03-24
10816349013635GuideRightLake Region MedicalDQX2026-03-24
10816349013642GuideRightLake Region MedicalDQX2026-03-24
10816349013659GuideRightLake Region MedicalDQX2026-03-24
10816349013666GuideRightLake Region MedicalDQX2026-03-24
10884450529581SplashWire™Merit Medical Systems, Inc.DQX2026-03-24
20801902193418ARROWTELEFLEX INCORPORATEDDQX2026-03-23
20801902221876ARROWTELEFLEX INCORPORATEDDQX2026-03-13
20801902221883ARROWTELEFLEX INCORPORATEDDQX2026-03-13
20801902221890ARROWTELEFLEX INCORPORATEDDQX2026-03-13
20801902225522ARROWTELEFLEX INCORPORATEDDQX2026-03-11
16936733736408ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-02-27
16936733736415ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-02-27
16936733736644ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-02-27
16936733736651ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-02-27
16936733736668ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-02-27
06936733736678ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-02-27
16936733736965ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-02-27
16936733736996ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-02-27
16936733737009ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-02-27
16936733737085ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-02-27