FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106136513
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
40-3938C
Catalog number
40-3938C
Device description
PACK ACCESS CENT VEN CATH REMO
Published
2023-03-30
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
50197106136513PackageGS150In Commercial Distribution
10197106136515PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710613651350197106136513
1019710613651510197106136515

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 Temperature040 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
20192253019992Kendall33547T33547T--2026-05-26
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
10198956328457CARDINAL HEALTHPG4ETRHTCPG4ETRHTC2026-05-25
10198956340435CARDINAL HEALTH08-4609B08-4609B2026-05-25
10198956345645CARDINAL HEALTHSEYCGVPCPHSEYCGVPCPH2026-05-25
10198956348189CARDINAL HEALTHSBA48PPNSESBA48PPNSE2026-05-25
10198956350205CARDINAL HEALTHORC431774CORC431774C2026-05-25
10198956354517CARDINAL HEALTHSOP44TSTODSOP44TSTOD2026-05-25
10198956358003CARDINAL HEALTHSOT53CYPZDSOT53CYPZD2026-05-25
10198956358904CARDINAL HEALTHSOP53ACVLFSOP53ACVLF2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956418905CARDINAL HEALTHCardinal Health 200, LLCOFE2026-03-16
50198956418903CARDINAL HEALTHCardinal Health 200, LLCOFE2026-03-16
10198956270497CARDINAL HEALTHCardinal Health 200, LLCOFE2025-11-21
10198956271142CARDINAL HEALTHCardinal Health 200, LLCOFE2025-11-21
10198956272651CARDINAL HEALTHCardinal Health 200, LLCOFE2025-11-21
10198956133433CARDINAL HEALTHCardinal Health 200, LLCOFE2025-07-10
10198956133716CARDINAL HEALTHCardinal Health 200, LLCOFE2025-07-10
50198956133431CARDINAL HEALTHCardinal Health 200, LLCOFE2025-07-10
50198956133714CARDINAL HEALTHCardinal Health 200, LLCOFE2025-07-10
10198956114296CARDINAL HEALTHCardinal Health 200, LLCOFE2025-06-24
10198956070653CARDINAL HEALTHCardinal Health 200, LLCOFE2025-06-06
50198956070651CARDINAL HEALTHCardinal Health 200, LLCOFE2025-06-06
10198956074347CARDINAL HEALTHCardinal Health 200, LLCOFE2025-05-15
50198956074345CARDINAL HEALTHCardinal Health 200, LLCOFE2025-05-15
10198956019737CARDINAL HEALTHCardinal Health 200, LLCOFE2025-03-25
50198956019735CARDINAL HEALTHCardinal Health 200, LLCOFE2025-03-25
10198956002685CARDINAL HEALTHCardinal Health 200, LLCOFE2025-03-21
50198956002683CARDINAL HEALTHCardinal Health 200, LLCOFE2025-03-21
10197106714690CARDINAL HEALTHCardinal Health 200, LLCOFE2024-07-08
50197106714698CARDINAL HEALTHCardinal Health 200, LLCOFE2024-07-08
10197106651339CARDINAL HEALTHCardinal Health 200, LLCOFE2024-04-29
50197106651337CARDINAL HEALTHCardinal Health 200, LLCOFE2024-04-29
10197106596593CARDINAL HEALTHCardinal Health 200, LLCOFE2024-03-08
50197106596591CARDINAL HEALTHCardinal Health 200, LLCOFE2024-03-08
10197106584514CARDINAL HEALTHCardinal Health 200, LLCOFE2024-02-26
50197106584512CARDINAL HEALTHCardinal Health 200, LLCOFE2024-02-26
10197106566534CARDINAL HEALTHCardinal Health 200, LLCOFE2024-02-08
50197106566532CARDINAL HEALTHCardinal Health 200, LLCOFE2024-02-08
10197106547397CARDINAL HEALTHCardinal Health 200, LLCOFE2024-01-29
50197106547395CARDINAL HEALTHCardinal Health 200, LLCOFE2024-01-29