FDA.report

Dover

Primary DI
10192253029970
Brand
Dover
Company
Cardinal Health 200, LLC
Model
5558492038
Catalog number
5558492038
Device description
Dover Urethral PVC Catheter
Published
2024-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
KODCATHETER, UROLOGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
KODCatheter, UrologicalGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50192253029978PrimaryGS10
10192253029970Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019225302997850192253029978
1019225302997010192253029970

GMDN Terms

TermDefinition
Intermittent urethral drainage catheter, antimicrobialA flexible or rigid, tube designed to be repeatedly inserted through the urethra, typically by the user (i.e., self-applied), to the urinary bladder to provide short-term, episodic urine drainage (removed after each void), typically for an individual who is physiologically incapable of voiding. Because of the potential frequency of catheterization, the device will typically be pre-lubricated or coated with/made of materials that facilitate easy insertion and removal; it is also coated with an antibiotic or antimicrobial agent to help prevent infection of the urinary tract. This is a reusable device on the same patient for a limited period of time.

Device Sizes

TypeValueUnit
Catheter Gauge12French

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
Device count
250
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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