FDA.reportPublic FDA data

Cure Medical Catheter Insertion Kit

Primary DI
10815947020465
Brand
Cure Medical Catheter Insertion Kit
Company
CURE MEDICAL LLC
Model
K1
Device description
Catheter Insertion Kit
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
OHRCatheter Care Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHRCatheter Care TrayGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10815947020465PackageGS1100In Commercial Distribution
00815947020468PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081594702046510815947020465
00815947020468008159470204688159470204680815947020468

GMDN Terms#

Term, Definition table
TermDefinition
Urethral catheterization support kit, urinary drainageA collection of sterile, non-surgically invasive devices intended to assist a healthcare professional to insert a urethral catheter (not included) into the urinary bladder, typically for drainage of urine; some types may also be intended for catheter removal. It typically includes forceps, dressings, gloves, and drapes; it does not include pharmaceuticals. This is a single-use device.

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
true
HCT/P
false
Kit
true
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
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
20815947020097Cure Catheter®M16C2016-09-24
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
10198459678653MEDLINEMEDLINE INDUSTRIES, INC.OHR2026-07-31
10198459678660MEDLINEMEDLINE INDUSTRIES, INC.OHR2026-07-31
10198459678677MEDLINEMEDLINE INDUSTRIES, INC.OHR2026-07-31
10198459678684MEDLINEMEDLINE INDUSTRIES, INC.OHR2026-07-31
10198459678691MEDLINEMEDLINE INDUSTRIES, INC.OHR2026-07-31
10198459679025MEDLINEMEDLINE INDUSTRIES, INC.OHR2026-07-31
00850067913023TruCath®HR PHARMACEUTICALS INC.OHR2026-07-23
10198956385054CARDINAL HEALTHCardinal Health 200, LLCOHR2026-04-27
10198956214569CARDINAL HEALTHCardinal Health 200, LLCOHR2025-11-28
10198956094376CARDINAL HEALTHCardinal Health 200, LLCOHR2025-08-25
10197106910979CARDINAL HEALTHCardinal Health 200, LLCOHR2025-04-23
10197344148981MEDLINEMEDLINE INDUSTRIES, INC.OHR2025-04-07
10197344148998MEDLINEMEDLINE INDUSTRIES, INC.OHR2025-04-02
10197344149001MEDLINEMEDLINE INDUSTRIES, INC.OHR2025-04-02
10197106963685CARDINAL HEALTHCardinal Health 200, LLCOHR2025-03-14
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00610075096619VaPro Plus Pocket KitHOLLISTER INCORPORATEDOHR2025-01-24
00610075096626VaPro Plus Pocket KitHOLLISTER INCORPORATEDOHR2025-01-24
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10198459028793Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2024-07-29
00610075095667VaPro Plus Pocket KitHOLLISTER INCORPORATEDOHR2024-07-15
00610075095674VaPro Plus Pocket KitHOLLISTER INCORPORATEDOHR2024-07-15
00610075095681VaPro Plus Pocket KitHOLLISTER INCORPORATEDOHR2024-07-15
00610075095698VaPro Plus Pocket KitHOLLISTER INCORPORATEDOHR2024-07-15
00610075095704VaPro Plus Pocket KitHOLLISTER INCORPORATEDOHR2024-07-15
10198459044588Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2024-06-23
10195327610999MedlineMEDLINE INDUSTRIES, INC.OHR2024-03-25
10193489834482MedlineMEDLINE INDUSTRIES, INC.OHR2024-03-05
10193489939262MedlineMEDLINE INDUSTRIES, INC.OHR2024-03-05