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
10197344144181MEDLINERTACIBDHPRTACIBDHP2026-08-07
10197344169429MEDLINEMSCSRG97310MSCSRG973102026-08-07
10197344169436MEDLINEMSCSRG97314MSCSRG973142026-08-07
10195327188955NAMICDYNJGWIRE20LDYNJGWIRE20L2022-08-04
10195327279776MedlineDNSC145169DNSC1451692023-06-13
10195327301057NAMICDYNJHWIRE100DYNJHWIRE1002023-01-29
10195327301590NAMICDYNJHWIRE101DYNJHWIRE1012023-01-29
10195327301606NAMICDYNJHWIRE102DYNJHWIRE1022023-01-29
10195327301613NAMICDYNJHWIRE103DYNJHWIRE1032023-01-29
10195327301620NAMICDYNJHWIRE104DYNJHWIRE1042023-01-29
10195327301637NAMICDYNJHWIRE105DYNJHWIRE1052023-01-29
10195327302153NAMICDYNJHWIRE106DYNJHWIRE1062023-01-29
10195327302184NAMICDYNJHWIRE107DYNJHWIRE1072023-01-29
10195327302191NAMICDYNJHWIRE108DYNJHWIRE1082023-01-29
10195327302207NAMICDYNJHWIRE109DYNJHWIRE1092023-01-29
10195327302214NAMICDYNJHWIRE110DYNJHWIRE1102023-01-29
10195327305987NAMICDYNJHWIRE111DYNJHWIRE1112023-01-29
10195327305994NAMICDYNJHWIRE112DYNJHWIRE1122023-01-29
10195327306007NAMICDYNJHWIRE113DYNJHWIRE1132023-01-29
10195327306014NAMICDYNJHWIRE114DYNJHWIRE1142023-05-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03661219288992LANDANGERLANDANGERLRP2026-08-09
03661219289050LANDANGERLANDANGERLRP2026-08-09
03661219289296LANDANGERLANDANGERLRP2026-08-09
10198459678653MEDLINEMEDLINE INDUSTRIES, INC.OHR2026-07-31
10198459678660MEDLINEMEDLINE INDUSTRIES, INC.OHR2026-07-31
10198459678677MEDLINEMEDLINE INDUSTRIES, INC.OHR2026-07-31
10198459678684MEDLINEMEDLINE INDUSTRIES, INC.OHR2026-07-31
10198459678691MEDLINEMEDLINE INDUSTRIES, INC.OHR2026-07-31
10198459679025MEDLINEMEDLINE INDUSTRIES, INC.OHR2026-07-31
10198956516014CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-31
10198956536043CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-31
10198956538313CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-31
04046826380830Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-07-30
04046826380939Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-07-30
04046826413187Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-07-30
04046826413194Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-07-30
04046826413200Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-07-30
04046826438180Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-07-30
04046826495800Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-07-30
04046826495954Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-07-30
00198506092343ELMED INCORPORATEDELMED INCORPORATEDLRP2026-07-29
03661219268444LANDANGERLANDANGERLRP2026-07-29
00198506093739ELMED INCORPORATEDELMED INCORPORATEDLRP2026-07-28
00642356005812SteriBestMastel Surgical Inc.LRP2026-07-28
08057639712660Box AdapterMC BIO SRLLRP2026-07-28
10198956414419CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956488236CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956489189CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956492745CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956493025CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27