FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50195594767394
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
19-8722B
Catalog number
19-8722B
Device description
NEONATAL UVC INSERTION TRAY
Published
2022-09-08
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
50195594767394PackageGS120In Commercial Distribution
10195594767396PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559476739450195594767394
1019559476739610195594767396

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
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50198956331639CARDINAL HEALTHCardinal Health 200, LLCPXJ2026-03-23
50198956218879CARDINAL HEALTHCardinal Health 200, LLCPXJ2026-02-09
50198956309775CARDINAL HEALTHCardinal Health 200, LLCPXJ2026-01-22
50198956303476CARDINAL HEALTHCardinal Health 200, LLCPXJ2026-01-07
50198956289565CARDINAL HEALTHCardinal Health 200, LLCPXJ2025-12-17
50198956289824CARDINAL HEALTHCardinal Health 200, LLCPXJ2025-12-11
50198956259605CARDINAL HEALTHCardinal Health 200, LLCPXJ2025-11-28
50198956127508CARDINAL HEALTHCardinal Health 200, LLCPXJ2025-06-25
50197106911424CARDINAL HEALTHCardinal Health 200, LLCPXJ2025-04-01
50197106855421CARDINAL HEALTHCardinal Health 200, LLCPXJ2025-01-13
50197106862436CARDINAL HEALTHCardinal Health 200, LLCPXJ2025-01-02
50197106863983CARDINAL HEALTHCardinal Health 200, LLCPXJ2024-12-11
00191072232373ACSAMERICAN CONTRACT SYSTEMS, INC.PXJ2024-11-24
50197106625796CARDINAL HEALTHCardinal Health 200, LLCPXJ2024-06-18
50197106523566CARDINAL HEALTHCardinal Health 200, LLCPXJ2024-01-24
50197106481101CARDINAL HEALTHCardinal Health 200, LLCPXJ2023-12-01
50197106487080CARDINAL HEALTHCardinal Health 200, LLCPXJ2023-11-28
50197106441525CARDINAL HEALTHCardinal Health 200, LLCPXJ2023-10-02
50197106348275CARDINAL HEALTHCardinal Health 200, LLCPXJ2023-06-29
50195594777270CARDINAL HEALTHCardinal Health 200, LLCPXJ2023-06-20
50197106256655CARDINAL HEALTHCardinal Health 200, LLCPXJ2023-05-04
50195594890054CARDINAL HEALTHCardinal Health 200, LLCPXJ2022-10-13
50195594722829CARDINAL HEALTHCardinal Health 200, LLCPXJ2022-10-12
50195594787453CARDINAL HEALTHCardinal Health 200, LLCPXJ2022-09-09
50195594795830CARDINAL HEALTHCardinal Health 200, LLCPXJ2022-09-08
50195594781703CARDINAL HEALTHCardinal Health 200, LLCPXJ2022-08-17
50195594738899CARDINAL HEALTHCardinal Health 200, LLCPXJ2022-07-26
50195594682369CARDINAL HEALTHCardinal Health 200, LLCPXJ2022-05-26
50195594548702CARDINAL HEALTHCardinal Health 200, LLCPXJ2022-04-29
50195594428288CARDINAL HEALTHCardinal Health 200, LLCPXJ2022-04-25