FDA.report

MEDLINE INDUSTRIES, INC.

Primary DI
40080196726463
Brand
MEDLINE INDUSTRIES, INC.
Company
MEDLINE INDUSTRIES, INC.
Model
DYND13510
Catalog number
DYND13510
Device description
CATHETER,URETHRAL,REDRUBBER,STRL,10FR
Published
2020-12-30
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
EYBCATHETER, URETERAL, GASTRO-UROLOGY
KODCATHETER, UROLOGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
EYBCatheter, Ureteral, Gastro-UrologyGastroenterology, Urology2
KODCatheter, UrologicalGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
40080196726463PackageGS112In Commercial Distribution
10080196726462PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
4008019672646340080196726463
1008019672646210080196726462

GMDN Terms

TermDefinition
Single-administration urethral drainage catheterA sterile, flexible tube intended to be inserted one-time through the urethra to the urinary bladder, by the patient/user or a healthcare provider, to provide urine drainage, typically for an individual who is physiologically incapable of voiding. It is typically made of polyvinyl chloride (PVC), and may be coated with a lubricating substance (e.g., acquires a smooth and mucous surface when brought in contact with water). The distal end can have various tip designs [e.g., open-ended, rounded with a side hole(s)], and the proximal end typically connects to a urine collection container. This is a single-use device.

Device Sizes

TypeValueUnit
Catheter Gauge10French

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Avoid excessive heat.; Store at room temperature.; Store product away from direct exposure to light.

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
true
No natural rubber latex
false
Sterilization required before use
false

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