FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594864200
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PU30UOP14
Catalog number
PU30UOP14
Device description
KIT, MP DR SUSONI UROLOGY PBDS
Published
2022-10-04
Public version status
New
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
NWUEndoscope introducer kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWUEndoscope Introducer KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594864208PackageGS11In Commercial Distribution
10195594864200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559486420850195594864208
1019559486420010195594864200

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 Temperature040 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
10192253004649Monoject8602RC8602RC2026-07-09
10192253004656Monoject8605RC8605RC2026-07-09
10192253004663Monoject8607RC8607RC2026-07-09
10192253004700Monoject8617RC8617RC2026-07-09
10192253051575Precision2650SA2650SA2026-07-09
10197106896327CARDINAL HEALTHSNENU0868BSNENU0868B2026-07-09
10198956074668CARDINAL HEALTHSBA37OTMOFSBA37OTMOF2026-07-09
10198956119260CARDINAL HEALTHSBA69MPSUBSBA69MPSUB2026-07-09
10198956119437CARDINAL HEALTHPVVMVPBLGPVVMVPBLG2026-07-09
10198956255586CARDINAL HEALTHSOP53SAPTHSOP53SAPTH2026-07-09
10198956268272CARDINAL HEALTHSMA54CSWMMSMA54CSWMM2026-07-09
10198956286719CARDINAL HEALTHSOT11BR10MSOT11BR10M2026-07-09
10198956307308CARDINAL HEALTHSAN43ADSWOSAN43ADSWO2026-07-09
10198956313576CARDINAL HEALTHSMA69BTDNBSMA69BTDNB2026-07-09
10198956333888CARDINAL HEALTHPBCGLSARGPBCGLSARG2026-07-09
10198956334373CARDINAL HEALTHSNECGBPNODSNECGBPNOD2026-07-09
10198956339132CARDINAL HEALTHSEYHDCAGWHSEYHDCAGWH2026-07-09
10198956345942CARDINAL HEALTHSANOCIRHTBSANOCIRHTB2026-07-09
10198956349834CARDINAL HEALTHSAN73PLCHMSAN73PLCHM2026-07-09
10198956360358CARDINAL HEALTHSCV73VPBHDSCV73VPBHD2026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956457768CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-09
10198956465749CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-09
10198956486065CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-09
10198956491939CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-09
10198956508286CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-09
10198956512382CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-09
10198956526686CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-09
10198956527621CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-09
10198956528260CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-09
10198956481435CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-06
10198956500631CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-06
10198956525061CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-06
10198956526358CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-06
10198956453791CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-23
10198956503465CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-23
10198956512399CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-23
10198956517523CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-23
10198956364349CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-08
10198956408739CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-08
10198956428775CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-08
10198956474673CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-08
10198956482272CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-08
10198956482562CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-08
10198956489684CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-08
10198956496309CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-08
10198956498037CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-08
10198956498600CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-08
10198956499164CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-08
10198956367630CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-05
10198956379855CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-05