FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50195594785527
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN30CEPRA
Catalog number
SAN30CEPRA
Device description
CENTRAL LINE
Published
2022-09-08
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
OFECentral venous blood pressure kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFECentral Venous Blood Pressure KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594785527PackageGS18In Commercial Distribution
10195594785529PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559478552750195594785527
1019559478552910195594785529

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.

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
50198956418903CARDINAL HEALTHCardinal Health 200, LLCOFE2026-03-16
50198956133431CARDINAL HEALTHCardinal Health 200, LLCOFE2025-07-10
50198956133714CARDINAL HEALTHCardinal Health 200, LLCOFE2025-07-10
50198956070651CARDINAL HEALTHCardinal Health 200, LLCOFE2025-06-06
50198956074345CARDINAL HEALTHCardinal Health 200, LLCOFE2025-05-15
50198956019735CARDINAL HEALTHCardinal Health 200, LLCOFE2025-03-25
50198956002683CARDINAL HEALTHCardinal Health 200, LLCOFE2025-03-21
50197106714698CARDINAL HEALTHCardinal Health 200, LLCOFE2024-07-08
50197106651337CARDINAL HEALTHCardinal Health 200, LLCOFE2024-04-29
50197106596591CARDINAL HEALTHCardinal Health 200, LLCOFE2024-03-08
50197106584512CARDINAL HEALTHCardinal Health 200, LLCOFE2024-02-26
50197106566532CARDINAL HEALTHCardinal Health 200, LLCOFE2024-02-08
50197106547395CARDINAL HEALTHCardinal Health 200, LLCOFE2024-01-29
50197106535170CARDINAL HEALTHCardinal Health 200, LLCOFE2024-01-16
50197106459339CARDINAL HEALTHCardinal Health 200, LLCOFE2023-10-12
50197106375080CARDINAL HEALTHCardinal Health 200, LLCOFE2023-08-11
50197106407996CARDINAL HEALTHCardinal Health 200, LLCOFE2023-08-11
50197106390540CARDINAL HEALTHCardinal Health 200, LLCOFE2023-08-01
50197106380282CARDINAL HEALTHCardinal Health 200, LLCOFE2023-07-21
50197106244515CARDINAL HEALTHCardinal Health 200, LLCOFE2023-06-05
50197106209477CARDINAL HEALTHCardinal Health 200, LLCOFE2023-04-05
50197106211425CARDINAL HEALTHCardinal Health 200, LLCOFE2023-04-05
50197106136513CARDINAL HEALTHCardinal Health 200, LLCOFE2023-03-30
50197106160822CARDINAL HEALTHCardinal Health 200, LLCOFE2023-03-08
50197106171156CARDINAL HEALTHCardinal Health 200, LLCOFE2023-03-08
50197106128631CARDINAL HEALTHCardinal Health 200, LLCOFE2023-02-16
50195594043320CARDINAL HEALTHCardinal Health 200, LLCOFE2022-11-02
50195594892454CARDINAL HEALTHCardinal Health 200, LLCOFE2022-10-27
50195594783936CARDINAL HEALTHCardinal Health 200, LLCOFE2022-10-20
50195594785558CARDINAL HEALTHCardinal Health 200, LLCOFE2022-09-14