FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10888439287318
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA18CTAM1
Catalog number
SBA18CTAM1
Device description
35043, CATHETER INSERTION
Published
2018-11-27
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

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
50888439287316PackageGS14In Commercial Distribution
10888439287318PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843928731650888439287316
1088843928731810888439287318

GMDN Terms#

Term, Definition table
TermDefinition
Urological surgical procedure kit, non-medicated, single-useA collection of various urological surgical instruments and the necessary materials intended to be used during a urological surgical/endoscopic procedure; it is not a dedicated bladder irrigation set. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of urological surgical procedure, but are often supplied together to perform a specific type of urological procedure; it does not contain any pharmaceuticals. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20885380214377KendallCB2LCB2L2026-10-12
20885380214384KendallCB2LITECB2LITE2026-10-12
20885380214391KendallCB2XLCB2XL2026-10-12
20885380214407KendallCB3LCB3L2026-10-12
20885380214414KendallCB4LCB4L2026-10-12
10192253046397Kendall55535PAMD55535PAMD2023-09-27
10192253046762Kendall55588BAMD55588BAMD2023-10-09
10885380173691Curity6309G6309G2019-11-14
20192253039358Kerlix458845882025-03-19
20192253039365Kerlix50425042-2025-03-19
20192253039372Kerlix61206120-2025-03-19
20192253039396Kerlix507250722025-03-19
20192253039594Kerlix258525852025-03-19
20885380173490Curity2556G2556G2019-11-14
20885380173513Curity2835G2835G2019-11-14
20192253008347CARDINAL HEALTH5005005005002020-09-24
20192253016632Kendall222002A222002A-2024-02-28
20192253016830Kendall30710001307100012024-02-28
20192253017813KendallEF00149EF001492024-02-28
20885380130950MEDI-VAC65652-11965652-1192018-03-06

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