FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106029916
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PGMVPANM6
Catalog number
PGMVPANM6
Device description
BEDSIDE PARACENTESIS SAFETY KI
Published
2022-11-18
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
PYBMinor surgical procedures tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PYBMinor Surgical Procedures TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106029914PackageGS13In Commercial Distribution
10197106029916PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710602991450197106029914
1019710602991610197106029916

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
10197106992753CARDINAL HEALTHSCV40VP52CSCV40VP52C2026-09-25
10198956169357CARDINAL HEALTHSCV69EVWKASCV69EVWKA2026-09-25
10198956172715CARDINAL HEALTHSBA21PPSCCSBA21PPSCC2026-09-25
10198956321335CARDINAL HEALTHPEHDTRVCKPEHDTRVCK2026-09-25
10198956339729CARDINAL HEALTHSBA22ATMRASBA22ATMRA2026-09-25
10198956374232CARDINAL HEALTHSOP41KASRBSOP41KASRB2026-09-25
10198956383043CARDINAL HEALTHORC3R7765BORC3R7765B2026-09-25
10198956388239CARDINAL HEALTHSOT53CYPOFSOT53CYPOF2026-09-25
10198956393288CARDINAL HEALTHSBA73GPMVBSBA73GPMVB2026-09-25
10198956400801CARDINAL HEALTHSOP3MHPCVCSOP3MHPCVC2026-09-25
10198956402522CARDINAL HEALTHSMA13GLEXDSMA13GLEXD2026-09-25
10198956424654CARDINAL HEALTHPO54TKCMDPO54TKCMD2026-09-25
10198956439849CARDINAL HEALTHSAN69PCKOGSAN69PCKOG2026-09-25
10198956444263CARDINAL HEALTHPV36HPCHEPV36HPCHE2026-09-25
10198956450684CARDINAL HEALTHSMA58CSLOPSMA58CSLOP2026-09-25
10198956461086CARDINAL HEALTHSBACGBPGSHSBACGBPGSH2026-09-25
10198956462205CARDINAL HEALTHPV08TCGHHPV08TCGHH2026-09-25
10198956466159CARDINAL HEALTH03-2656S03-2656S2026-09-25
10198956466838CARDINAL HEALTHSNE35LSFSGSNE35LSFSG2026-09-25
10198956484382CARDINAL HEALTHANE306276AANE306276A2026-09-25

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00844107000996Arbutus MedicalArbutus Medical IncPYB2026-09-24
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00844107000903Arbutus MedicalArbutus Medical IncPYB2026-06-22
00844107000934Arbutus MedicalArbutus Medical IncPYB2026-06-22
00844107000958Arbutus MedicalArbutus Medical IncPYB2026-06-22
00844107000972Arbutus MedicalArbutus Medical IncPYB2026-06-22
00844107000989Arbutus MedicalArbutus Medical IncPYB2026-06-22
00844107000736Arbutus MedicalArbutus Medical IncPYB2026-04-28
00844107000750Arbutus MedicalArbutus Medical IncPYB2026-04-28
00844107000781Arbutus MedicalArbutus Medical IncPYB2026-04-28
00844107000828Arbutus MedicalArbutus Medical IncPYB2026-04-28
00884450116913Merit Medical®Merit Medical Systems, Inc.PYB2025-09-09
00884450096529Merit Medical®Merit Medical Systems, Inc.PYB2025-07-01
00884450089897Merit Medical®Merit Medical Systems, Inc.PYB2025-05-20
00840365908623InvenioGri-Alleset, Inc.PYB2025-03-12
00884450185261Merit Medical®Merit Medical Systems, Inc.PYB2023-01-04
M7526821425R10STRADIS HEALTHCARESTRADIS MEDICAL, LLCPYB2022-12-22
H65857031545Henry ScheinHENRY SCHEIN, INC.PYB2022-08-25
H65857030875Henry ScheinHENRY SCHEIN, INC.PYB2022-05-25
00884450187494Merit Medical®Merit Medical Systems, Inc.PYB2021-10-28
00844107000637Arbutus MedicalArbutus Medical IncPYB2021-10-19
00884450186428Merit Medical®Merit Medical Systems, Inc.PYB2021-03-03
00884450248805Merit Medical®Merit Medical Systems, Inc.PYB2019-10-31
00884450055144PAL™Merit Medical Systems, Inc.PYB2018-09-17
00884450166062Merit Medical®Merit Medical Systems, Inc.PYB2018-09-17
00884450049556Merit Medical®Merit Medical Systems, Inc.PYB2018-09-14
00884450049570Merit Medical®Merit Medical Systems, Inc.PYB2018-09-14
00884450049587Merit Medical®Merit Medical Systems, Inc.PYB2018-09-14
00884450049594Merit Medical®Merit Medical Systems, Inc.PYB2018-09-14