FDA.report

Medline

Primary DI
20193489100270
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
URO10441
Catalog number
URO10441
Device description
KIT,CATH,SELF,MY-CATH,TOUCH-FREE,14FR
Published
2022-12-01
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

Related Records

Contact Domains

Product Codes

CodeName
FCMTray, catheterization, sterile urethral, with or without catheter (kit)

Product Code Classifications

CodeDeviceSpecialtyClass
FCMTray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)Gastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20193489100270PackageGS160In Commercial Distribution
10193489100273PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019348910027020193489100270
1019348910027310193489100273

GMDN Terms

TermDefinition
Intermittent urethral catheterization kitA collection of devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories (e.g., gloves, drapes, tray) intended for self-urinary catheterization. The catheter may be repeatedly inserted through the urethra by the user to provide short-term, episodic urine drainage. It is typically pre-lubricated or coated with, made of, or includes materials/substances that facilitate easy insertion and removal [e.g., polytetrafluoroethylene (PTFT) commonly known as Teflon, or glass]; it might also be coated with or include antimicrobial materials/substances to help prevent infection of the urinary tract. This is a reusable device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store product away from direct exposure to light at room temperature.

Sterilization Methods

Method

Contacts

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

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