FDA.reportPublic FDA data

Medline

Primary DI
40080196996750
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
DYND18350
Catalog number
DYND18350
Device description
TRAY,URETHRAL,CATHETER,RED-RUBBER,15FR
Published
2021-08-06
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
OHRCatheter care tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHRCatheter Care TrayGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40080196996750PackageGS120In Commercial Distribution
10080196996759PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4008019699675040080196996750
1008019699675910080196996759

GMDN Terms#

Term, Definition table
TermDefinition
Single-administration urethral catheterization kit, single-useA sterile collection of devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories intended for one-time, self-urinary catheterization. The catheter is inserted through the urethra by the patient to provide urine drainage. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge15French

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
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
true
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
10198956385054CARDINAL HEALTHCardinal Health 200, LLCOHR2026-04-27
10198956214569CARDINAL HEALTHCardinal Health 200, LLCOHR2025-11-28
10198956094376CARDINAL HEALTHCardinal Health 200, LLCOHR2025-08-25
10197106910979CARDINAL HEALTHCardinal Health 200, LLCOHR2025-04-23
10197344148981MEDLINEMEDLINE INDUSTRIES, INC.OHR2025-04-07
10197344148998MEDLINEMEDLINE INDUSTRIES, INC.OHR2025-04-02
10197344149001MEDLINEMEDLINE INDUSTRIES, INC.OHR2025-04-02
10197106963685CARDINAL HEALTHCardinal Health 200, LLCOHR2025-03-14
10198459028793Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2024-07-29
10809160429389Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OHR2024-07-10
10198459044588Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2024-06-23
10195327610999MedlineMEDLINE INDUSTRIES, INC.OHR2024-03-25
10193489834482MedlineMEDLINE INDUSTRIES, INC.OHR2024-03-05
10193489939262MedlineMEDLINE INDUSTRIES, INC.OHR2024-03-05
10080196997084MedlineMEDLINE INDUSTRIES, INC.OHR2023-12-28
10195327468880Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2023-12-21
10653160995791Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.OHR2023-12-21
10850053289191SURGYCOSurgyco LLCOHR2023-12-15
10195327443023Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2023-10-15
10195327443108Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2023-10-15
10197106420386CARDINAL HEALTHCardinal Health 200, LLCOHR2023-10-12
10195327512514Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2023-10-01
10195327503192Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2023-09-17
10610075177063ApogeeHOLLISTER INCORPORATEDOHR2023-08-22
10195327476946Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2023-08-13
10195327245474Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2023-07-29
10653160995517Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.OHR2023-07-29
10195327195236MedlineMEDLINE INDUSTRIES, INC.OHR2023-06-08
10195327242862MedlineMEDLINE INDUSTRIES, INC.OHR2023-06-08
10653160995067Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.OHR2023-04-30