FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594683870
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PGMVTHN17
Catalog number
PGMVTHN17
Device description
KIT, BEDSIDE THORACENTESIS SFT
Published
2022-05-26
Public version status
Update
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
50195594683878PackageGS14In Commercial Distribution
10195594683870PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559468387850195594683878
1019559468387010195594683870

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, 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
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
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
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