FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106328910
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
30-CE2COAA
Catalog number
30-CE2COAA
Device description
CENTESIS 5FRX10 ASPIRATING NDL
Published
2023-06-16
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
PYCParacentesis tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PYCParacentesis TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106328918PackageGS110In Commercial Distribution
10197106328910PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710632891850197106328918
1019710632891010197106328910

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
10885380213281CARDINAL HEALTHCAH4403CAH44032026-05-27
10192253047486Telfa766776672025-09-08
50885380140233CONVERTORS8337N8337N2018-08-20
10192253047967Kendall92339233-2026-05-26
20192253019992Kendall33547T33547T--2026-05-26
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
10198956328457CARDINAL HEALTHPG4ETRHTCPG4ETRHTC2026-05-25
10198956340435CARDINAL HEALTH08-4609B08-4609B2026-05-25
10198956345645CARDINAL HEALTHSEYCGVPCPHSEYCGVPCPH2026-05-25
10198956348189CARDINAL HEALTHSBA48PPNSESBA48PPNSE2026-05-25
10198956350205CARDINAL HEALTHORC431774CORC431774C2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956454835CARDINAL HEALTHCardinal Health 200, LLCPYC2026-05-08
10198956400351CARDINAL HEALTHCardinal Health 200, LLCPYC2026-03-06
50198956400359CARDINAL HEALTHCardinal Health 200, LLCPYC2026-03-06
10198956303607CARDINAL HEALTHCardinal Health 200, LLCPYC2026-01-13
50198956303605CARDINAL HEALTHCardinal Health 200, LLCPYC2026-01-13
10198956196452CARDINAL HEALTHCardinal Health 200, LLCPYC2025-11-21
10198956223318CARDINAL HEALTHCardinal Health 200, LLCPYC2025-11-07
10198956179677CARDINAL HEALTHCardinal Health 200, LLCPYC2025-08-27
50198956179675CARDINAL HEALTHCardinal Health 200, LLCPYC2025-08-27
10198956100251CARDINAL HEALTHCardinal Health 200, LLCPYC2025-07-15
50198956100259CARDINAL HEALTHCardinal Health 200, LLCPYC2025-07-15
10198956082342CARDINAL HEALTHCardinal Health 200, LLCPYC2025-06-09
50198956082340CARDINAL HEALTHCardinal Health 200, LLCPYC2025-06-09
10198956056121CARDINAL HEALTHCardinal Health 200, LLCPYC2025-05-07
50198956056129CARDINAL HEALTHCardinal Health 200, LLCPYC2025-05-07
10197106886809CARDINAL HEALTHCardinal Health 200, LLCPYC2025-04-07
50197106886807CARDINAL HEALTHCardinal Health 200, LLCPYC2025-04-07
10197106914205CARDINAL HEALTHCardinal Health 200, LLCPYC2025-02-17
50197106914203CARDINAL HEALTHCardinal Health 200, LLCPYC2025-02-17
10197106881606CARDINAL HEALTHCardinal Health 200, LLCPYC2025-01-21
50197106881604CARDINAL HEALTHCardinal Health 200, LLCPYC2025-01-21
00884450809310Merit Medical®Merit Medical Systems, Inc.PYC2024-12-28
10884450809317Merit Medical®Merit Medical Systems, Inc.PYC2024-12-28
10197106793305CARDINAL HEALTHCardinal Health 200, LLCPYC2024-12-12
50197106793303CARDINAL HEALTHCardinal Health 200, LLCPYC2024-12-12
10197106471746CARDINAL HEALTHCardinal Health 200, LLCPYC2024-04-26
50197106471744CARDINAL HEALTHCardinal Health 200, LLCPYC2024-04-26
10197106569948CARDINAL HEALTHCardinal Health 200, LLCPYC2024-02-12
50197106569946CARDINAL HEALTHCardinal Health 200, LLCPYC2024-02-12
10197106425626CARDINAL HEALTHCardinal Health 200, LLCPYC2023-11-27