FDA.reportPublic FDA data

Cure Catheter®

Primary DI
20815947020097
Brand
Cure Catheter®
Company
CURE MEDICAL LLC
Model
M16C
Device description
Sterile Intermittent Urinary Catheter with Funnel End, Coudé Tip
Published
2016-09-24
Public version status
Update
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
GBMCatheter, Urethral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBMCatheter, UrethralGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072539000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072539000CURE CATHETERCure Medical, LLC2007-09-13EZD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10815947020090PackageGS130In Commercial Distribution
20815947020097PackageGS110In Commercial Distribution
00815947020093PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081594702009010815947020090
2081594702009720815947020097
00815947020093008159470200938159470200930815947020093

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge16French
Length16Inch
Length41Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+18004228811cic@convatec.com

Regulatory Flags#

DUNS number
070643426
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
10815947021257Cure DextraDEX142020-08-28
10815947021264Cure DextraDEX162020-08-28
10815947021271Cure DextraDEX182020-08-28
10815947020465Cure Medical Catheter Insertion KitK12016-09-24
20815947020011Cure Catheter®M102016-09-24
20815947020028Cure Catheter®M122016-09-24
20815947020035Cure Catheter®M142016-09-24
20815947020042Cure Catheter®M162016-09-24
20815947020059Cure Catheter®M182016-09-24
20815947020066Cure Catheter®M10C2016-09-24
20815947020073Cure Catheter®M12C2016-09-24
20815947020080Cure Catheter®M14C2016-09-24
20815947020103Cure Catheter®M18C2016-09-24
20815947020110Cure Catheter®M12U2016-09-24
20815947020127Cure Catheter®M14U2016-09-24
20815947020134Cure Catheter®M16U2016-09-24
20815947020158Cure Pocket Coude™M12ULC2016-12-30
20815947020165Cure Pocket Coude™M14ULC2016-12-30
20815947020172Cure Pocket Coude™M16ULC2016-12-30
20815947020189Cure Catheter®F82016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14026704943019TELEFLEXTELEFLEX INCORPORATEDGBM2026-04-10
14026704943026TELEFLEXTELEFLEX INCORPORATEDGBM2026-04-10
14026704943033TELEFLEXTELEFLEX INCORPORATEDGBM2026-04-10
14026704943040TELEFLEXTELEFLEX INCORPORATEDGBM2026-04-10
14026704943057TELEFLEXTELEFLEX INCORPORATEDGBM2026-04-10
14026704943125TELEFLEXTELEFLEX INCORPORATEDGBM2026-04-10
14026704943132TELEFLEXTELEFLEX INCORPORATEDGBM2026-04-10
14026704943149TELEFLEXTELEFLEX INCORPORATEDGBM2026-04-10
14026704943170TELEFLEXTELEFLEX INCORPORATEDGBM2026-04-10
14026704943194TELEFLEXTELEFLEX INCORPORATEDGBM2026-04-10
14026704943255TELEFLEXTELEFLEX INCORPORATEDGBM2026-04-10
10192253058437DoverCardinal Health 200, LLCGBM2025-01-23
10192253058444DoverCardinal Health 200, LLCGBM2025-01-23
10192253058451DoverCardinal Health 200, LLCGBM2025-01-23
10192253058468DoverCardinal Health 200, LLCGBM2025-01-23
10192253058475DoverCardinal Health 200, LLCGBM2025-01-23
10192253058482DoverCardinal Health 200, LLCGBM2025-01-23
10192253058499DoverCardinal Health 200, LLCGBM2025-01-23
10192253058505DoverCardinal Health 200, LLCGBM2025-01-23
10192253058512DoverCardinal Health 200, LLCGBM2025-01-23
10192253058529DoverCardinal Health 200, LLCGBM2025-01-23
10192253058536DoverCardinal Health 200, LLCGBM2025-01-23
10192253058543DoverCardinal Health 200, LLCGBM2025-01-23
00610075094394VaPro Plus PocketHOLLISTER INCORPORATEDGBM2024-06-26
00610075094400VaPro Plus PocketHOLLISTER INCORPORATEDGBM2024-06-26
00610075094424VaPro Plus PocketHOLLISTER INCORPORATEDGBM2024-06-26
00610075094431VaPro Plus PocketHOLLISTER INCORPORATEDGBM2024-06-26
00610075094448VaPro Plus PocketHOLLISTER INCORPORATEDGBM2024-06-26
00610075094462VaPro Plus PocketHOLLISTER INCORPORATEDGBM2024-06-26
10192253027761DoverCardinal Health 200, LLCGBM2022-11-08