FDA.reportPublic FDA data

Medline

Primary DI
40080196846727
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
DYND10701
Catalog number
DYND10701
Device description
CATHETER,URETHRAL,VINYL,FEMALE,6",10FR
Published
2021-01-06
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
KODCATHETER, UROLOGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KODCatheter, UrologicalGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40080196846727PackageGS130In Commercial Distribution
10080196846726PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4008019684672740080196846727
1008019684672610080196846726

GMDN Terms#

Term, Definition table
TermDefinition
Intermittent urethral drainage catheter, non-antimicrobial, single-useA flexible or rigid tube designed for a single insertion into the urethra, typically by the user (i.e., self-applied), to the urinary bladder to provide urine drainage, typically for an individual who is physiologically incapable of voiding. The device is typically pre-lubricated or coated with/made of materials that facilitate easy insertion and removal [e.g., polytetrafluoroethylene (PTFT) - Teflon, or glass] and is disposed of after use; it does not include an antimicrobial agent(s). The device may be male or female dedicated. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge10French
Length6Inch

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
false
HCT/P
false
Kit
false
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
24026704942057RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
04026704942060RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
04026704942077RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
24026704942088RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
24026704942095RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
24026704942101RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
04026704942114RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
24026704942125RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
04026704942138RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
24026704942149RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
04026704942152RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
24026704942163RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
24026704942170RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
04026704942183RUSCHTELEFLEX INCORPORATEDKOD2026-03-23
20192253024255DoverCardinal Health 200, LLCKOD2026-03-20
50192253024263DoverCardinal Health 200, LLCKOD2026-03-20
50192253024270DoverCardinal Health 200, LLCKOD2026-03-20
50192253024300DoverCardinal Health 200, LLCKOD2026-03-20
20885380202596DoverCardinal Health 200, LLCKOD2026-03-20
50850058254673EZ-Advancer®HR PHARMACEUTICALS INC.KOD2026-03-06
04026704937158RUSCHTELEFLEX INCORPORATEDKOD2026-02-27
34026704937166RUSCHTELEFLEX INCORPORATEDKOD2026-02-27
04026704937172RUSCHTELEFLEX INCORPORATEDKOD2026-02-27
34026704937180RUSCHTELEFLEX INCORPORATEDKOD2026-02-27
04026704937196RUSCHTELEFLEX INCORPORATEDKOD2026-02-27
34026704937203RUSCHTELEFLEX INCORPORATEDKOD2026-02-27
20854913006185Urinary Catheter, 16 FrUROGEN PHARMA LTDKOD2025-11-17
20854913006192Urinary Catheter, 16 FrUROGEN PHARMA LTDKOD2025-11-17
20854913006154Urinary Catheter, 16 FrUROGEN PHARMA LTDKOD2025-11-16
20854913006161Urinary Catheter, 16 FrUROGEN PHARMA LTDKOD2025-11-16