FDA.report

Luja Coude

Primary DI
05701780263399
Brand
Luja Coude
Company
Coloplast A/S
Model
20112
Catalog number
20112
Published
2023-09-07
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
EZDCatheter, straight

Product Code Classifications

CodeDeviceSpecialtyClass
EZDCatheter, StraightGastroenterology, Urology2

Premarket Submissions

SubmissionSupplement
K230165000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K230165000Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10 - small packaging (Pocket size)), Luja Coudé (20112 Male CH12 - small packaging (Pocket size)), Luja Coudé (20114 Male CH14 - small packaging (Pocket size)), Luja Coudé (20101 Male CH10 - large packaging), Luja Coudé (20102 Male CH12 - large packaging), Luja Coudé (20104 Male CH14 - large packaging), Luja Coudé (20106 Male CH16 - large packaging)Coloplast2023-08-25EZD

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05701780263306PackageGS130In Commercial Distribution
05701780263399PackageGS14In Commercial Distribution
05701780263214PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05701780263306057017802633065701780263306
05701780263399057017802633995701780263399
05701780263214057017802632145701780263214

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 Gauge12French
Catheter Working Length12.9Inch
Catheter Working Length33Centimeter
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight. Do not use if package is damaged and consult IFU.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)533-0464healthcarecs@coloplast.com

Regulatory Flags

DUNS number
305524696
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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