FDA.reportPublic FDA data

Medline

Primary DI
40888277331632
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
DYNCX1816
Catalog number
DYNCX1816
Device description
TRAY,CATHETER,URETHRAL,RED-RUBBER,15FR
Published
2016-10-14
Public version status
Update
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
FCMTray, catheterization, sterile urethral, with or without catheter (kit)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCMTray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)Gastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40888277331632PackageGS120In Commercial Distribution
10888277331631PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4088827733163240888277331632
1088827733163110888277331631

GMDN Terms#

Term, Definition table
TermDefinition
Indwelling urethral catheterization kitA collection of sterile devices that includes an indwelling urethral catheter (commonly known as a Foley catheter), gloves, lubricating gel, and other related accessories intended for the drainage of urine from the bladder. The catheter has an inflatable balloon at the distal tip for retention in the urinary bladder after its insertion through the urethra, where it usually functions as an indwelling therapeutic device for urinary incontinence or as a means to void for non-ambulatory patients. The catheter will be applied by trained staff and may or may not be coated with an antibiotic to help prevent catheter-associated urinary tract infection (CAUTI). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temprature

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
false
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

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50192253068564DoverCardinal Health 200, LLCFCM2026-01-16
50192253068571DoverCardinal Health 200, LLCFCM2026-01-16
50192253068588DoverCardinal Health 200, LLCFCM2026-01-16
50192253068595DoverCardinal Health 200, LLCFCM2026-01-16
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50192253068663DoverCardinal Health 200, LLCFCM2026-01-16
50192253068700DoverCardinal Health 200, LLCFCM2026-01-16
50192253067956DoverCardinal Health 200, LLCFCM2026-01-15
50192253067994DoverCardinal Health 200, LLCFCM2026-01-15
50192253068007DoverCardinal Health 200, LLCFCM2026-01-15
50192253070857DoverCardinal Health 200, LLCFCM2026-01-15
50192253027752DoverCardinal Health 200, LLCFCM2025-12-10
50192253028834DoverCardinal Health 200, LLCFCM2025-12-10
50192253028841DoverCardinal Health 200, LLCFCM2025-12-10
50192253030172DoverCardinal Health 200, LLCFCM2025-10-17
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40704411019610AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01
40704411019627AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01
40704411019634AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01