FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956586802
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SCV33AFUWA
Catalog number
SCV33AFUWA
Device description
AV FISTULA PACK
Published
2026-10-12
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

Product Codes#

Code, Name table
CodeName
OEZCardiovascular procedure kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEZCardiovascular Procedure KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956586800PackageGS12In Commercial Distribution
10198956586802PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895658680050198956586800
1019895658680210198956586802

GMDN Terms#

Term, Definition table
TermDefinition
Cardiothoracic surgical procedure kit, medicated, single-useA collection of various sterile cardiothoracic surgical instruments, dressings, and materials including a pharmaceutical component, intended to be used to assist a range of cardiothoracic surgical procedures. The kit is intended only for use during cardiothoracic surgery but is not dedicated to a specific type of cardiothoracic surgical procedure. This is a single-use device intended to be sterilized prior to use.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Regulatory Flags#

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10198956077348CARDINAL HEALTHSCV57RAKPQSCV57RAKPQ2026-10-12
10198956137547CARDINAL HEALTHPV35VKMBCPV35VKMBC2026-10-12
10198956194632CARDINAL HEALTHSAN33MPMPCSAN33MPMPC2026-10-12
10198956276437CARDINAL HEALTHSOPCNBERVBSOPCNBERVB2026-10-12
10198956301719CARDINAL HEALTHSOP53PKBSCSOP53PKBSC2026-10-12
10198956331259CARDINAL HEALTH32-1024F32-1024F2026-10-12
10198956333611CARDINAL HEALTHPOCGHNWTGPOCGHNWTG2026-10-12
10198956352230CARDINAL HEALTHSAN40SLRWBSAN40SLRWB2026-10-12
10198956361041CARDINAL HEALTHSOP44SPKSCSOP44SPKSC2026-10-12
10198956384439CARDINAL HEALTHSOP32LSISFSOP32LSISF2026-10-12
10198956388376CARDINAL HEALTHSOPCGTHOMESOPCGTHOME2026-10-12
10198956391239CARDINAL HEALTHSOT12CYMOCSOT12CYMOC2026-10-12
10198956399051CARDINAL HEALTHSUT44BPSCBSUT44BPSCB2026-10-12
10198956421240CARDINAL HEALTHSEY23CTRCPSEY23CTRCP2026-10-12
10198956460393CARDINAL HEALTHSEN30EEPRBSEN30EEPRB2026-10-12
10198956463875CARDINAL HEALTH02-0891H02-0891H2026-10-12
10198956471887CARDINAL HEALTHSCV54VCWMUSCV54VCWMU2026-10-12
10198956491298CARDINAL HEALTH31-1019F31-1019F2026-10-12
10198956493803CARDINAL HEALTHSNE11CR83GSNE11CR83G2026-10-12
10198956507425CARDINAL HEALTHSBA42BPSMBSBA42BPSMB2026-10-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956077348CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956137547CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956194632CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956471887CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956518421CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956538467CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956541672CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956554085CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956569362CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956575042CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956576957CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956581227CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956584372CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956586987CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956587212CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956591783CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956596481CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956599147CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956599178CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956599185CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956599383CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956599390CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956599451CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956599802CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956600324CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956600348CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956600379CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956600560CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956601413CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956601420CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12