FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50888439577486
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA32UVMEF
Catalog number
SBA32UVMEF
Device description
UMBILICAL VESSEL TRAY
Published
2019-10-31
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
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
50888439577486PackageGS12In Commercial Distribution
10888439577488PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843957748650888439577486
1088843957748810888439577488

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA general-purpose collection of various sterile surgical instruments, dressings, and materials, including a pharmaceutical component, intended to be used to assist a range of surgical procedures across multiple clinical specialities. This is a single-use device.

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
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253046205Webcol511051102024-09-05
10192253047066Webcol68186818-2025-06-10
10192253047073Webcol6818-16818-12025-07-28
10884521008427Dover502750272016-09-24
10885380052538CARDINAL HEALTHC-CB2SC-CB2S2023-08-07
10885380052545CARDINAL HEALTHC-CB3SC-CB3S2023-08-07
10885380052569CARDINAL HEALTHC-CB6SC-CB6S2023-08-07
10885380052613CARDINAL HEALTHC-CB6C-CB62023-08-07
10885380107801CARDINAL HEALTHABP1201ABP12012016-07-22
10885380107818CARDINAL HEALTHASC1201ASC12012016-07-22
10885380107825CARDINAL HEALTHASC1210ASC12102016-07-22
10885380107832CARDINAL HEALTHASC1211ASC12112016-07-22
10885380107849CARDINAL HEALTHASC1220ASC12202016-07-22
10885380107856CARDINAL HEALTHASC1221ASC12212016-07-22

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