FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
40884389410289
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYND25207
Catalog number
DYND25207
Device description
BAG,DRAINAGE,ANTI-REFLUX DEVCE
Published
2016-11-07
Public version status
Update
Distribution status
Not 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
PADChest drainage kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PADChest Drainage KitGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40884389410289PackageGS120Not in Commercial Distribution
10884389410288PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4088438941028940884389410289
1088438941028810884389410288

GMDN Terms#

Term, Definition table
TermDefinition
Indwelling urethral catheterization kit, adultA collection of devices that includes an indwelling urethral catheter which incorporates a balloon (commonly known as a Foley catheter), and devices associated with catheter introduction/function (e.g., gloves, lubricating gel, drapes), intended for urinary drainage from the bladder of an adult or paediatric patient. The catheter will be applied by trained staff and may be coated with an antibiotic to help prevent catheter-associated urinary tract infection (CAUTI). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
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
10080196144310MEDLINEDYNDX51813DYNDX518132026-06-08
10884389123997MEDLINEDYNDX50251DYNDX502512026-06-08
10080196301904MedlineMDS10781MDS107812016-10-14
10080196301898MedlineMDS10780MDS107802016-10-14
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04015588940040medisanaElectrical Appliance Branch of Zhangzhou Easepal Industrial CorporationPAD2024-05-22
10889942488575Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PAD2021-07-27
10889942455959Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PAD2021-06-11
00817617028156CuraplexBOUND TREE MEDICAL, LLCPAD2017-09-04
10080196659630Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PAD2016-11-07
10884389410288Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PAD2016-11-07
10888277996892Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PAD2016-11-07
10884389362969Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PAD2016-11-07