FDA.reportPublic FDA data

Medline

Primary DI
10080196028559
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
DYND10200
Catalog number
DYND10200
Device description
TRAY,FOLEY INSERTION,PVP,30ML SYRINGE
Published
2020-12-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRPTRAY, SURGICAL
OHRCatheter care tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRPTray, SurgicalGeneral, Plastic Surgery1
OHRCatheter Care TrayGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40080196028550PackageGS120In Commercial Distribution
10080196028559PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4008019602855040080196028550
1008019602855910080196028559

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.

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
Kit
true
Lot or batch
true
Expiration date on label
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
10198956309012CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-03
10198956404243CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-03
10198956437159CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-03
10198956489134CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-03
10198956495579CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-03
10198956495616CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-03
10198956501607CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-03
10198956501850CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-03
10198956397057CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-01
10198956408722CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-01
10198956441798CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-01
10198956446366CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-01
10198956471351CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-01
10198956485761CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-01
10198956492684CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-01
10198956493513CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-01
10198956495425CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-01
10198956498983CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-01
10198956500389CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-01
07649988948725SPIRECUTSPIRECUT SALRP2026-05-04
G586961003A0Novo SurgicalNOVO SURGICAL, INC.LRP2024-02-22
10080196997084MedlineMEDLINE INDUSTRIES, INC.OHR2023-12-28
G429MSS820160Stainless steel bowl small 6CMMEED SKILL SURGICALLRP2023-03-03
G141588222990Carnegie Surgical LLCCarnegie Surgical LLCLRP2023-02-13
07899798205796QuinelatoSchobell Industrial LtdaLRP2022-12-20
10193489097269MedlineMEDLINE INDUSTRIES, INC.OHR2022-12-17
10193489088281MedlineMEDLINE INDUSTRIES, INC.OHR2022-11-30
10193489088298MedlineMEDLINE INDUSTRIES, INC.OHR2022-11-30
10193489097276MedlineMEDLINE INDUSTRIES, INC.OHR2022-11-30
10193489090765MedlineMEDLINE INDUSTRIES, INC.OHR2022-04-08