FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
40193489411561
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNDC5003G
Catalog number
DYNDC5003G
Device description
DBL DRP DIALYSIS DRSG CHNG KIT
Published
2023-06-08
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
MCYWound dressing kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MCYWound Dressing KitGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40193489411561PackageGS125In Commercial Distribution
10193489411560PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019348941156140193489411561
1019348941156010193489411560

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
false
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
true
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
40198459428624MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MCY2025-07-21
40198459433475MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MCY2025-07-21
10661392000831LSL HEALTHCARELSL Industries, LLCMCY2025-05-16
10661392007946LSL HEALTHCARELSL Industries, LLCMCY2025-05-16
10661392007953LSL HEALTHCARELSL Industries, LLCMCY2025-05-16
10661392007960LSL HEALTHCARELSL Industries, LLCMCY2025-05-16
10661392007977LSL HEALTHCARELSL Industries, LLCMCY2025-05-16
10661392008622LSL HEALTHCARELSL Industries, LLCMCY2025-05-16
10661392053691LSL HEALTHCARELSL Industries, LLCMCY2025-05-16
10661392000787LSL HEALTHCARELSL Industries, LLCMCY2025-05-15
40198459171780Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2024-11-24
00653160381511MEDLINEMEDLINE INDUSTRIES, INC.MCY2024-10-28
40198459057930Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2024-10-20
40195327657834Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2024-07-29
40195327667925Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2024-07-29
40198459053840Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2024-06-30
00850003042404carePACExtremity CareMCY2024-02-06
10850003042418carePACExtremity CareMCY2024-02-06
10850003042425carePACExtremity CareMCY2024-02-06
10850003042432carePACExtremity CareMCY2024-02-06
10850003042449carePACExtremity CareMCY2024-02-06
10850003042456carePACExtremity CareMCY2024-02-06
00850003042466carePACExtremity CareMCY2024-02-06
20850003042477carePACExtremity CareMCY2024-02-06
05060418833565Susol® Wound Debridement Pack (Pack of 10)BAILEY INSTRUMENTS LTDMCY2024-01-23
05060418835996Susol® Ulcer Debridement Pack USA (Pack of 10)BAILEY INSTRUMENTS LTDMCY2024-01-23
05060418836726Susol® Ulcer Debridement Pack (Pack of 10)BAILEY INSTRUMENTS LTDMCY2024-01-23
40195327559183Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-12-21
00850050570097Wound CareKitMirodx, LLCMCY2023-11-06
00850050570103Wound CareKitMirodx, LLCMCY2023-11-06