FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106328789
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
OTC
false
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

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
10198956037908CARDINAL HEALTH08-3641G08-3641G2026-09-04
10198956210240CARDINAL HEALTHAMN213116EAMN213116E2026-09-04
10198956310933CARDINAL HEALTHANE439532GANE439532G2026-09-04
10198956331891CARDINAL HEALTHSAN13ARBIFSAN13ARBIF2026-09-04
10198956333420CARDINAL HEALTHSANX4IPSSCSANX4IPSSC2026-09-04
10198956359291CARDINAL HEALTHSMA54BGEVCSMA54BGEVC2026-09-04
10198956379084CARDINAL HEALTHSOP33EXMSGSOP33EXMSG2026-09-04
10198956395947CARDINAL HEALTHSOPMIMPMSBSOPMIMPMSB2026-09-04
10198956398467CARDINAL HEALTHSBA44LPCEASBA44LPCEA2026-09-04
10198956415195CARDINAL HEALTHSCVCGOHILHSCVCGOHILH2026-09-04
10198956421462CARDINAL HEALTHSOPMVSAUCJSOPMVSAUCJ2026-09-04
10198956426061CARDINAL HEALTHSCVDKMVOGDSCVDKMVOGD2026-09-04
10198956428102CARDINAL HEALTHSAN13RDEMSSAN13RDEMS2026-09-04
10198956454989CARDINAL HEALTHSOP23KPNLCSOP23KPNLC2026-09-04
10198956462977CARDINAL HEALTHSBA48LCRHCSBA48LCRHC2026-09-04
10198956463394CARDINAL HEALTHSEN23TAPCLSEN23TAPCL2026-09-04
10198956464520CARDINAL HEALTHSMA23GPNVBSMA23GPNVB2026-09-04
10198956465510CARDINAL HEALTH34-3217C34-3217C2026-09-04
10198956468399CARDINAL HEALTHPO1DTHAMQPO1DTHAMQ2026-09-04
10198956468481CARDINAL HEALTHSMAOCGLSTGSMAOCGLSTG2026-09-04

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
10197106328781CARDINAL 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