FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50198956133431
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SCV56UVIH1
Catalog number
SCV56UVIH1
Device description
PACK OB UMBILICA CATH IHC
Published
2025-07-10
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
50198956133431PackageGS12In Commercial Distribution
10198956133433PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895613343150198956133431
1019895613343310198956133433

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
10198956037908CARDINAL HEALTH08-3641G08-3641G2026-09-04
10198956210240CARDINAL HEALTHAMN213116EAMN213116E2026-09-04
10198956310933CARDINAL HEALTHANE439532GANE439532G2026-09-04
10198956331891CARDINAL HEALTHSAN13ARBIFSAN13ARBIF2026-09-04
10198956333420CARDINAL HEALTHSANX4IPSSCSANX4IPSSC2026-09-04
10198956359291CARDINAL HEALTHSMA54BGEVCSMA54BGEVC2026-09-04
10198956379084CARDINAL HEALTHSOP33EXMSGSOP33EXMSG2026-09-04
10198956395947CARDINAL HEALTHSOPMIMPMSBSOPMIMPMSB2026-09-04
10198956398467CARDINAL HEALTHSBA44LPCEASBA44LPCEA2026-09-04
10198956415195CARDINAL HEALTHSCVCGOHILHSCVCGOHILH2026-09-04
10198956421462CARDINAL HEALTHSOPMVSAUCJSOPMVSAUCJ2026-09-04
10198956426061CARDINAL HEALTHSCVDKMVOGDSCVDKMVOGD2026-09-04
10198956428102CARDINAL HEALTHSAN13RDEMSSAN13RDEMS2026-09-04
10198956454989CARDINAL HEALTHSOP23KPNLCSOP23KPNLC2026-09-04
10198956462977CARDINAL HEALTHSBA48LCRHCSBA48LCRHC2026-09-04
10198956463394CARDINAL HEALTHSEN23TAPCLSEN23TAPCL2026-09-04
10198956464520CARDINAL HEALTHSMA23GPNVBSMA23GPNVB2026-09-04
10198956465510CARDINAL HEALTH34-3217C34-3217C2026-09-04
10198956468399CARDINAL HEALTHPO1DTHAMQPO1DTHAMQ2026-09-04
10198956468481CARDINAL HEALTHSMAOCGLSTGSMAOCGLSTG2026-09-04

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
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
10197106535172CARDINAL HEALTHCardinal Health 200, LLCOFE2024-01-16