FDA.reportPublic FDA data

GentleCath Hydrophilic Kit

Primary DI
07333387043975
Brand
GentleCath Hydrophilic Kit
Company
Wellspect AB
Model
509006
Catalog number
509006
Device description
Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Female 8'' 12FR
Published
2024-06-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EYYDrape, urological, disposable
EZDCatheter, straight
FAQBAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE
LYZVinyl patient examination glove
NWOKit, catheter, urinary (exludes HIV testing)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EYYDrape, Urological, DisposableGeneral, Plastic Surgery2
EZDCatheter, StraightGastroenterology, Urology2
FAQBag, Urine Collection, Leg, For External Use, SterileGastroenterology, Urology1
LYZVinyl Patient Examination GloveGeneral Hospital1
NWOKit, Catheter, Urinary (Exludes Hiv Testing)Gastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07333387043982PackageGS110In Commercial Distribution
07333387043999PackageGS14In Commercial Distribution
00768455142743PreviousGS10
07333387043975PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
07333387043982073333870439827333387043982
07333387043999073333870439997333387043999
00768455142743007684551427437684551427430768455142743
07333387043975073333870439757333387043975

GMDN Terms#

Term, Definition table
TermDefinition
Single-administration urethral catheterization kit, single-useA sterile collection of devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories intended for one-time, self-urinary catheterization. The catheter is inserted through the urethra by the patient to provide urine drainage. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge12French
Length8Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry

Contacts#

Phone, Email table
PhoneEmail
+1(800)422-8818cic@convatec.com

Regulatory Flags#

DUNS number
351118942
Device count
1
DM exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07333387055695LoFric Elle Pro41910502026-05-20
07333387055725LoFric Elle Pro41912502026-05-20
07333387055756LoFric Elle Pro41914502026-05-20
07333387056623Surity Male External Catheter3802138021402026-04-27
07333387056630Surity Female External Catheter3801138011402025-12-19
07333387055329Surity Female External Catheter38011380112025-12-19
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07333387054421LoFric® Origo™4471644716402025-07-25
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07333387002217LoFric® Origo™4451444514402024-08-25

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