FDA.reportPublic FDA data

SimPro™ Set

Primary DI
07333387043548
Brand
SimPro™ Set
Company
Wellspect AB
Model
5331000
Catalog number
5331000
Device description
Single Use Urinary Catheter with water sachet and Accessories. Fem/Ped Nelaton 8" 10FR
Published
2023-08-28
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
NWOKit, catheter, urinary (exludes HIV testing)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWOKit, Catheter, Urinary (Exludes Hiv Testing)Gastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07333387043531PackageGS110In Commercial Distribution
07333387043548PackageGS14In Commercial Distribution
07392532189128PreviousGS10
07333387043524PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07333387043531073333870435317333387043531
07333387043548073333870435487333387043548
07392532189128073925321891287392532189128
07333387043524073333870435247333387043524

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 Gauge10French
Length8Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry place at room temperature.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)456-3742AnkaraTUR-Info@wellspect.com

Regulatory Flags#

DUNS number
351118942
Device count
1
DM exempt
false
Premarket exempt
false
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
false
Sterilization required before use
false

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
07333387053110LoFric® Origo™4491244912402025-11-24
07333387053127LoFric® Origo™4491444914402025-11-24
07333387053134LoFric® Origo™4491644916402025-11-24
07333387054537LoFric® Origo™4491244912402025-11-24
07333387054575LoFric® Origo™4491444914402025-11-24
07333387054605LoFric® Origo™4491644916402025-11-24
07333387052953LoFric® Origo™4471244712402025-07-25
07333387053059LoFric® Origo™4471444714402025-07-25
07333387053066LoFric® Origo™4471644716402025-07-25
07333387054353LoFric® Origo™4471244712402025-07-25
07333387054377LoFric® Origo™4471444714402025-07-25
07333387054421LoFric® Origo™4471644716402025-07-25
07333387002200LoFric® Origo™4451244512402024-08-25
07333387002217LoFric® Origo™4451444514402024-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07333387043913GentleCath Hydrophilic KitWellspect ABNWO2024-06-01
07333387043944GentleCath Hydrophilic KitWellspect ABNWO2024-06-01
07333387043975GentleCath Hydrophilic KitWellspect ABNWO2024-06-01
07333387044002GentleCath Hydrophilic KitWellspect ABNWO2024-06-01
07333387044033GentleCath Hydrophilic KitWellspect ABNWO2024-06-01
07333387044064GentleCath Hydrophilic KitWellspect ABNWO2024-06-01
07333387044095GentleCath Hydrophilic KitWellspect ABNWO2024-06-01
07333387044125GentleCath Hydrophilic KitWellspect ABNWO2024-06-01
07333387044156GentleCath Hydrophilic KitWellspect ABNWO2024-06-01
07333387044187GentleCath Hydrophilic KitWellspect ABNWO2024-06-01
07333387044217GentleCath Hydrophilic KitWellspect ABNWO2024-06-01
07333387044248GentleCath Hydrophilic KitWellspect ABNWO2024-06-01
07333387044279GentleCath Hydrophilic KitWellspect ABNWO2024-06-01
07333387044309GentleCath Hydrophilic KitWellspect ABNWO2024-06-01
07333387044330GentleCath Hydrophilic KitWellspect ABNWO2024-06-01
07333387044361GentleCath Hydrophilic KitWellspect ABNWO2024-06-01
07333387043999GentleCathTMOASIS MEDIKAL URUNLER KIMYA TURIZM SANAYI VE TICARET ANONIM SIRKETINWO2024-06-01
07333387044170GentleCathTMOASIS MEDIKAL URUNLER KIMYA TURIZM SANAYI VE TICARET ANONIM SIRKETINWO2024-06-01
07333387044255GentleCathTMOASIS MEDIKAL URUNLER KIMYA TURIZM SANAYI VE TICARET ANONIM SIRKETINWO2024-06-01
07333387043678SimPro™ SetWellspect ABNWO2024-05-02
07333387043739SimPro™ SetWellspect ABNWO2024-05-02
07333387043852SimPro™ SetWellspect ABNWO2024-05-02
07333387043494SimPro™ SetWellspect ABNWO2024-05-01
07333387043555SimPro™ SetWellspect ABNWO2024-05-01
07333387043616SimPro™ SetWellspect ABNWO2024-05-01
07333387043647SimPro™ SetWellspect ABNWO2024-05-01
07333387043579SimPro™ SetWellspect ABNWO2024-05-01
07333387043524SimPro™ SetWellspect ABNWO2023-08-28
07333387043586SimPro™ SetWellspect ABNWO2023-08-28
07333387043708SimPro™ SetWellspect ABNWO2023-08-28