FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50888439840610
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
09-8121A
Catalog number
09-8121A
Device description
UMBILICAL VESSEL TRAY
Published
2020-06-24
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
50888439840610PackageGS124In Commercial Distribution
10888439840612PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843984061050888439840610
1088843984061210888439840612

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.

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
10192253004649Monoject8602RC8602RC2026-07-09
10192253004656Monoject8605RC8605RC2026-07-09
10192253004663Monoject8607RC8607RC2026-07-09
10192253004700Monoject8617RC8617RC2026-07-09
10192253051575Precision2650SA2650SA2026-07-09
10197106896327CARDINAL HEALTHSNENU0868BSNENU0868B2026-07-09
10198956074668CARDINAL HEALTHSBA37OTMOFSBA37OTMOF2026-07-09
10198956119260CARDINAL HEALTHSBA69MPSUBSBA69MPSUB2026-07-09
10198956119437CARDINAL HEALTHPVVMVPBLGPVVMVPBLG2026-07-09
10198956255586CARDINAL HEALTHSOP53SAPTHSOP53SAPTH2026-07-09
10198956268272CARDINAL HEALTHSMA54CSWMMSMA54CSWMM2026-07-09
10198956286719CARDINAL HEALTHSOT11BR10MSOT11BR10M2026-07-09
10198956307308CARDINAL HEALTHSAN43ADSWOSAN43ADSWO2026-07-09
10198956313576CARDINAL HEALTHSMA69BTDNBSMA69BTDNB2026-07-09
10198956333888CARDINAL HEALTHPBCGLSARGPBCGLSARG2026-07-09
10198956334373CARDINAL HEALTHSNECGBPNODSNECGBPNOD2026-07-09
10198956339132CARDINAL HEALTHSEYHDCAGWHSEYHDCAGWH2026-07-09
10198956345942CARDINAL HEALTHSANOCIRHTBSANOCIRHTB2026-07-09
10198956349834CARDINAL HEALTHSAN73PLCHMSAN73PLCHM2026-07-09
10198956360358CARDINAL HEALTHSCV73VPBHDSCV73VPBHD2026-07-09

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