FDA.reportPublic FDA data

CURE MEDICAL

Primary DI
00815947020703
Brand
CURE MEDICAL
Company
CONVATEC, PURCHASING DEPARTMENT
Model
ET1
Device description
"29"" Cure Catheter Extension Tube with Connector"
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NNZSystem, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNZSystem, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-SterileGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10815947020700PackageGS130In Commercial Distribution
20815947020707PackageGS124In Commercial Distribution
00815947020703PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081594702070010815947020700
2081594702070720815947020707
00815947020703008159470207038159470207030815947020703

GMDN Terms#

Term, Definition table
TermDefinition
Low-pressure tubing connector, reusableA device designed to connect together two or more tubes typically with the intention of creating an extension. The connecting ends of this device will typically be serrated to provide a secure grip for the applied tubes. Clips or other forms of locking devices may be applied over the tubes to further secure the fitting. This device will not be appropriate for connecting tubes that are designed to carry (withstand) high pressures [e.g., high pressure gases]. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length74Centimeter

Regulatory Flags#

DUNS number
809784593
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00768455201303AVELLE4466504466502023-02-22
00768455108268STOMAHESIVE0255102022-09-28
00768455101399ACTIVELIFE0209222018-11-09
00768455101405ACTIVELIFE0227502018-11-09
00768455101412ACTIVELIFE0227512018-11-09
00768455101429ACTIVELIFE0227522018-11-09
00768455101436ACTIVELIFE0227532018-11-09
00768455101443ACTIVELIFE227542018-11-09
00768455101450ACTIVELIFE0227552018-11-09
00768455101467ACTIVELIFE0227562018-11-09
00768455101474ACTIVELIFE0227572018-11-09
00768455101481ACTIVELIFE0227582018-11-09
00768455101498ACTIVELIFE0227592018-11-09
00768455101504ACTIVELIFE0227602018-11-09
00768455101511ACTIVELIFE0227612018-11-09
00768455101528ACTIVELIFE0227622018-11-16
00768455101535ACTIVELIFE0227632018-11-16
00768455101542ACTIVELIFE0227642018-11-16
00768455101559ACTIVELIFE0227652018-11-16
00768455101566ACTIVELIFE0227662018-11-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00610075093458HollisterHOLLISTER INCORPORATEDNNZ2022-12-01
00610075093465HollisterHOLLISTER INCORPORATEDNNZ2022-12-01
20610075093452HollisterHOLLISTER INCORPORATEDNNZ2022-12-01
20610075093469HollisterHOLLISTER INCORPORATEDNNZ2022-12-01
00840216101609ASP MEDICALAsp Global, LLCNNZ2022-04-15
10840216101606ASP MEDICALASP GLOBAL, LLCNNZ2022-04-15
05055788767640Leg Bag Holder Extra LargeFLEXICARE MEDICAL LIMITEDNNZ2020-03-25
05055788767671Leg Bag Holder LargeFLEXICARE MEDICAL LIMITEDNNZ2020-03-25
05055788767701Leg Bag Holder MediumFLEXICARE MEDICAL LIMITEDNNZ2020-03-25
05055788767732Leg Bag Holder SmallFLEXICARE MEDICAL LIMITEDNNZ2020-03-25
20815947020707Cure Medical®CURE MEDICAL LLCNNZ2016-09-24