FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106952397
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN12IIUV2
Catalog number
SAN12IIUV2
Device description
CVC INFANT INSERTION PACK
Published
2025-02-24
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
OFFCentral venous catheter tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFFCentral Venous Catheter TrayCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106952397PackageGS15In Commercial Distribution
10197106952399PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710695239750197106952397
1019710695239910197106952399

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 Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

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
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20809160515218MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.OFF2026-03-06
20809160515003Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFF2026-03-04
20809160515027Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFF2026-03-04
50198956373165CARDINAL HEALTHCardinal Health 200, LLCOFF2026-03-03
50198956326369CARDINAL HEALTHCardinal Health 200, LLCOFF2026-03-02
50198956390964CARDINAL HEALTHCardinal Health 200, LLCOFF2026-03-02
50198956326277CARDINAL HEALTHCardinal Health 200, LLCOFF2026-02-13
20809160512255MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.OFF2026-02-11
50198956344592CARDINAL HEALTHCardinal Health 200, LLCOFF2026-02-09
50198956350661CARDINAL HEALTHCardinal Health 200, LLCOFF2026-02-09
50198956351880CARDINAL HEALTHCardinal Health 200, LLCOFF2026-02-09
50198956325058CARDINAL HEALTHCardinal Health 200, LLCOFF2026-01-15
00191072241597ACSAMERICAN CONTRACT SYSTEMS, INC.OFF2026-01-14
00191072241399ACSAMERICAN CONTRACT SYSTEMS, INC.OFF2026-01-06
00191072241405ACSAMERICAN CONTRACT SYSTEMS, INC.OFF2026-01-06
50198956302943CARDINAL HEALTHCardinal Health 200, LLCOFF2025-12-26
20809160506650Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFF2025-12-17
50198956285864CARDINAL HEALTHCardinal Health 200, LLCOFF2025-12-11
50198956263688CARDINAL HEALTHCardinal Health 200, LLCOFF2025-12-10
20809160495183Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFF2025-09-24
50198956070729CARDINAL HEALTHCardinal Health 200, LLCOFF2025-08-28
20809160492755MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.OFF2025-08-25
40198459326685MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFF2025-08-18
40198459440589MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFF2025-08-18
40198459454968MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFF2025-08-18
40198459469474MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFF2025-08-18
40198459469481MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFF2025-08-18
40198459472696MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFF2025-08-18
40198459481551MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFF2025-08-18
40198459406370MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFF2025-08-11