FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106328781
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
30-CE8SFA
Catalog number
30-CE8SFA
Device description
THORA PARA CATHETER DRAINAGE
Published
2023-08-21
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
PXIThoracentesis tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PXIThoracentesis TrayGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106328789PackageGS110In Commercial Distribution
10197106328781PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710632878950197106328789
1019710632878110197106328781

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
10198956182004CARDINAL HEALTHSOPCNEPBSFSOPCNEPBSF2026-07-06
10198956202320CARDINAL HEALTH34-9397L34-9397L2026-07-06
10198956261952CARDINAL HEALTH08-1780F08-1780F2026-07-06
10198956331235CARDINAL HEALTH32-7479R32-7479R2026-07-06
10198956358942CARDINAL HEALTHSEN4LTAGRCSEN4LTAGRC2026-07-06
10198956373068CARDINAL HEALTHSOP53HIOHCSOP53HIOHC2026-07-06
10198956373655CARDINAL HEALTHSANCGANMWCSANCGANMWC2026-07-06
10198956380615CARDINAL HEALTHENDDK4659DENDDK4659D2026-07-06
10198956381124CARDINAL HEALTH34-0950C34-0950C2026-07-06
10198956388789CARDINAL HEALTHSMA11DCWNFSMA11DCWNF2026-07-06
10198956389007CARDINAL HEALTHSEN35ENCFDSEN35ENCFD2026-07-06
10198956393424CARDINAL HEALTHSBADHLPNVCSBADHLPNVC2026-07-06
10198956397361CARDINAL HEALTHSAN29MY87ISAN29MY87I2026-07-06
10198956398689CARDINAL HEALTHSAN3MARCVCSAN3MARCVC2026-07-06
10198956407053CARDINAL HEALTHSOP69TJMSBSOP69TJMSB2026-07-06
10198956414693CARDINAL HEALTHSOP48TKLODSOP48TKLOD2026-07-06
10198956416079CARDINAL HEALTHPN11SF36DPN11SF36D2026-07-06
10198956416482CARDINAL HEALTHSAN11CC26CSAN11CC26C2026-07-06
10198956423077CARDINAL HEALTHPBCGDCBLIPBCGDCBLI2026-07-06
10198956427198CARDINAL HEALTHSBA13SMBTBSBA13SMBTB2026-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956402898CARDINAL HEALTHCardinal Health 200, LLCPXI2026-04-15
10198956364219CARDINAL HEALTHCardinal Health 200, LLCPXI2026-02-17
50198956364217CARDINAL HEALTHCardinal Health 200, LLCPXI2026-02-17
10198956327948CARDINAL HEALTHCardinal Health 200, LLCPXI2026-02-12
10198956161825CARDINAL HEALTHCardinal Health 200, LLCPXI2025-11-07
10198956127333CARDINAL HEALTHCardinal Health 200, LLCPXI2025-07-22
50198956127331CARDINAL HEALTHCardinal Health 200, LLCPXI2025-07-22
10198956074835CARDINAL HEALTHCardinal Health 200, LLCPXI2025-06-05
50198956074833CARDINAL HEALTHCardinal Health 200, LLCPXI2025-06-05
10198956051324CARDINAL HEALTHCardinal Health 200, LLCPXI2025-04-23
50198956051322CARDINAL HEALTHCardinal Health 200, LLCPXI2025-04-23
10197106646472CARDINAL HEALTHCardinal Health 200, LLCPXI2024-05-30
50197106646470CARDINAL HEALTHCardinal Health 200, LLCPXI2024-05-30
16931918132648InvenioGRI Medical & Electronic Technology Co., Ltd.PXI2024-04-26
26931918132645InvenioGRI Medical & Electronic Technology Co., Ltd.PXI2024-04-26
16931918164335InvenioGRI Medical & Electronic Technology Co., Ltd.PXI2024-02-02
26931918164332InvenioGRI Medical & Electronic Technology Co., Ltd.PXI2024-02-02
16931918171470InvenioGRI Medical & Electronic Technology Co., Ltd.PXI2023-10-27
16931918190280InvenioGRI Medical & Electronic Technology Co., Ltd.PXI2023-10-27
26931918171477InvenioGRI Medical & Electronic Technology Co., Ltd.PXI2023-10-27
26931918190287InvenioGRI Medical & Electronic Technology Co., Ltd.PXI2023-10-27
16931918121215InvenioGRI Medical & Electronic Technology Co., Ltd.PXI2023-10-20
26931918121212InvenioGRI Medical & Electronic Technology Co., Ltd.PXI2023-10-20
50197106328789CARDINAL HEALTHCardinal Health 200, LLCPXI2023-08-21
10197106150702CARDINAL HEALTHCardinal Health 200, LLCPXI2023-05-01
50197106150700CARDINAL HEALTHCardinal Health 200, LLCPXI2023-05-01
00884450277843Thoracentesis and Paracentesis SetMerit Medical Systems, Inc.PXI2022-12-02
10884450277840Thoracentesis and Paracentesis SetMerit Medical Systems, Inc.PXI2022-12-02
00884450277751Thoracentesis and Paracentesis SetMerit Medical Systems, Inc.PXI2022-10-18
10884450277758Thoracentesis and Paracentesis SetMerit Medical Systems, Inc.PXI2022-10-18