FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594633929
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA11CACH7
Catalog number
SBA11CACH7
Device description
CUTDOWN UMBILICAL ARTERY PACK
Published
2022-04-13
Public version status
Update
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
PXJUmbilical catheter insertion tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PXJUmbilical Catheter Insertion TrayGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594633927PackageGS15In Commercial Distribution
10195594633929PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559463392750195594633927
1019559463392910195594633929

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

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
10885380184895CARDINAL HEALTH82021820212024-07-25
10885380184901CARDINAL HEALTH82022820222024-07-25
10885380184918CARDINAL HEALTH82023820232024-07-25
10885380184925CARDINAL HEALTH82024820242024-07-25
50885380004818CONVERTORS9423N9423N2016-06-21
50885380009837CONVERTORS29455NA29455NA2016-06-21
50885380016972CONVERTORS29557N29557N2016-06-21
50885380020016CONVERTORS9450N9450N2016-06-21
50885380027916CONVERTORS9441N9441N2016-06-21
50885380030619CONVERTORS29444N29444N2016-06-21
50885380034068CONVERTORS29527N29527N2016-06-21
50885380034402CONVERTORS29559N29559N2016-06-21
50885380036116CONVERTORS9449N9449N2016-06-21
50885380053755CONVERTORS29421NB29421NB2016-06-21
50885380053779CONVERTORS9438NB9438NB2016-06-21
50885380053854CONVERTORS29465NB29465NB2016-06-21
50885380053878CONVERTORS29467NB29467NB2016-06-21
50885380053892CONVERTORS29522NB29522NB2016-06-21
50885380053922CONVERTORS9430NB9430NB2016-06-21
50885380053939CONVERTORS9458NB9458NB2016-06-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956331631CARDINAL HEALTHCardinal Health 200, LLCPXJ2026-03-23
50198956331639CARDINAL HEALTHCardinal Health 200, LLCPXJ2026-03-23
10198956218871CARDINAL HEALTHCardinal Health 200, LLCPXJ2026-02-09
50198956218879CARDINAL HEALTHCardinal Health 200, LLCPXJ2026-02-09
10198956309777CARDINAL HEALTHCardinal Health 200, LLCPXJ2026-01-22
50198956309775CARDINAL HEALTHCardinal Health 200, LLCPXJ2026-01-22
10198956303478CARDINAL HEALTHCardinal Health 200, LLCPXJ2026-01-07
50198956303476CARDINAL HEALTHCardinal Health 200, LLCPXJ2026-01-07
10198956289567CARDINAL HEALTHCardinal Health 200, LLCPXJ2025-12-17
50198956289565CARDINAL HEALTHCardinal Health 200, LLCPXJ2025-12-17
10198956289826CARDINAL HEALTHCardinal Health 200, LLCPXJ2025-12-11
50198956289824CARDINAL HEALTHCardinal Health 200, LLCPXJ2025-12-11
10198956259607CARDINAL HEALTHCardinal Health 200, LLCPXJ2025-11-28
50198956259605CARDINAL HEALTHCardinal Health 200, LLCPXJ2025-11-28
10198956237346CARDINAL HEALTHCardinal Health 200, LLCPXJ2025-11-10
10198956127500CARDINAL HEALTHCardinal Health 200, LLCPXJ2025-06-25
50198956127508CARDINAL HEALTHCardinal Health 200, LLCPXJ2025-06-25
10197106911426CARDINAL HEALTHCardinal Health 200, LLCPXJ2025-04-01
50197106911424CARDINAL HEALTHCardinal Health 200, LLCPXJ2025-04-01
10197106855423CARDINAL HEALTHCardinal Health 200, LLCPXJ2025-01-13
50197106855421CARDINAL HEALTHCardinal Health 200, LLCPXJ2025-01-13
10197106862438CARDINAL HEALTHCardinal Health 200, LLCPXJ2025-01-02
50197106862436CARDINAL HEALTHCardinal Health 200, LLCPXJ2025-01-02
10197106863985CARDINAL HEALTHCardinal Health 200, LLCPXJ2024-12-11
50197106863983CARDINAL HEALTHCardinal Health 200, LLCPXJ2024-12-11
00191072232373ACSAMERICAN CONTRACT SYSTEMS, INC.PXJ2024-11-24
10197106625798CARDINAL HEALTHCardinal Health 200, LLCPXJ2024-06-18
50197106625796CARDINAL HEALTHCardinal Health 200, LLCPXJ2024-06-18
10197106523568CARDINAL HEALTHCardinal Health 200, LLCPXJ2024-01-24
50197106523566CARDINAL HEALTHCardinal Health 200, LLCPXJ2024-01-24