FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956272651
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SCV56UVIH5
Catalog number
SCV56UVIH5
Device description
PACK OB UMBILICA CATH IHC
Published
2025-11-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
50198956272659PackageGS12In Commercial Distribution
10198956272651PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895627265950198956272659
1019895627265110198956272651

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

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253015553T.E.D.399539952026-06-19
20192253016748Kendall22853228532021-05-19
20192253016755Kendall2285522855-2021-02-23
20192253017455Kendall31469219314692192021-05-05
20192253017547Medi-Trace Cadence22550A22550A-2021-07-28
20192253017554Medi-Trace Cadence22550P22550P-2021-08-19
20192253017578Medi-Trace Cadence22550PC22550PC2021-07-29
20192253017585Medi-Trace Cadence22550R22550R-2021-07-29
20192253017608Medi-Trace Cadence22660R22660R-2024-02-28
20192253017622Medi-Trace Cadence22770P22770P2021-08-19
20192253017639Medi-Trace Cadence22770PC22770PC2021-07-29
20192253017721Kendall31319281313192812021-05-05
20192253018889Medi-Trace Cadence22770R22770R-2021-07-29
20192253020240Kerlix332433242020-09-22
50192253020197Kerlix189218922020-08-12
50192253020357Kerlix673567352020-08-12
50192253020364Kerlix788278822020-08-12
50192253050422Devon31142931311429312023-07-10
20192253017592Medi-Trace Cadence22660PC22660PC2021-07-29
10198956037908CARDINAL HEALTH08-3641G08-3641G2026-09-04

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
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
10197106535172CARDINAL HEALTHCardinal Health 200, LLCOFE2024-01-16