FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956520554
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SCV3DCPMMU
Catalog number
SCV3DCPMMU
Device description
CAROTID PACK
Published
2026-09-22
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
50198956520552PackageGS12In Commercial Distribution
10198956520554PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895652055250198956520552
1019895652055410198956520554

GMDN Terms#

Term, Definition table
TermDefinition
Cardiothoracic surgical procedure kit, non-medicated, single-useA collection of various sterile cardiothoracic surgical instruments, dressings, and materials intended to be used to assist a range of cardiothoracic surgical procedures; it does not contain pharmaceuticals. 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.

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
10192253004489SharpSafety85221852212026-09-24
10192253004502Monoject8522Y8522Y2026-09-24
10192253004557Monoject8533Y8533Y2026-09-24
10192253004571Monoject8536SA8536SA2026-09-24
10192253004632SharpSafety8541SA8541SA2026-09-24
10192253005059Monoject89651896512026-09-24
10192253005080Monoject8967Y8967Y2026-09-24
10192253005493Monoject8506Y8506Y2026-09-24
20885380075169CARDINAL HEALTHUSA-N95-SUSA-N95-S2016-08-02
20885380075183CARDINAL HEALTHUSA-N95-RUSA-N95-R2016-08-02
10198956271418CARDINAL HEALTHSMADKCSOGDSMADKCSOGD2026-09-22
10198956273979CARDINAL HEALTHSNE41APFMASNE41APFMA2026-09-22
10198956313897CARDINAL HEALTHSNE69CRWHESNE69CRWHE2026-09-22
10198956320598CARDINAL HEALTH28-1807Z28-1807Z2026-09-22
10198956333758CARDINAL HEALTHSMA73GLKCHSMA73GLKCH2026-09-22
10198956336667CARDINAL HEALTHSBA57PIOHQSBA57PIOHQ2026-09-22
10198956338661CARDINAL HEALTH08-8060I08-8060I2026-09-22
10198956339255CARDINAL HEALTHSAN23CCPRFSAN23CCPRF2026-09-22
10198956346222CARDINAL HEALTHSMAHDRLAGBSMAHDRLAGB2026-09-22
10198956350434CARDINAL HEALTHPE23THMEHPE23THMEH2026-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450435526Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-22
00884450445419Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-22
00884450473313Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-22
10198956508903CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956520783CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956524255CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956547384CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956566750CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956571464CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956575080CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956575950CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956578104CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956579347CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956579606CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956579682CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956580572CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956580657CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956580817CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956581289CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956581531CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956582101CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956582460CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956582750CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956583214CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956583351CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956583429CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956584631CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956585171CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956585812CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22
10198956585911CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-22