FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106328925
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
30-CE16SFA
Catalog number
30-CE16SFA
Device description
SAFE CENT 6FRX5 CATH MERIT
Published
2023-07-25
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
PYCParacentesis tray

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106328925PackageGS116In Commercial Distribution
10197106328927PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710632892550197106328925
1019710632892710197106328927

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
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50198956400359CARDINAL HEALTHCardinal Health 200, LLCPYC2026-03-06
50198956303605CARDINAL HEALTHCardinal Health 200, LLCPYC2026-01-13
50198956179675CARDINAL HEALTHCardinal Health 200, LLCPYC2025-08-27
50198956100259CARDINAL HEALTHCardinal Health 200, LLCPYC2025-07-15
50198956082340CARDINAL HEALTHCardinal Health 200, LLCPYC2025-06-09
50198956056129CARDINAL HEALTHCardinal Health 200, LLCPYC2025-05-07
50197106886807CARDINAL HEALTHCardinal Health 200, LLCPYC2025-04-07
50197106914203CARDINAL HEALTHCardinal Health 200, LLCPYC2025-02-17
50197106881604CARDINAL HEALTHCardinal Health 200, LLCPYC2025-01-21
10884450809317Merit Medical®Merit Medical Systems, Inc.PYC2024-12-28
50197106793303CARDINAL HEALTHCardinal Health 200, LLCPYC2024-12-12
50197106471744CARDINAL HEALTHCardinal Health 200, LLCPYC2024-04-26
50197106569946CARDINAL HEALTHCardinal Health 200, LLCPYC2024-02-12
50197106425624CARDINAL HEALTHCardinal Health 200, LLCPYC2023-11-27
50197106326273CARDINAL HEALTHCardinal Health 200, LLCPYC2023-08-29
10884450277666Safety Paracentesis Procedure TrayMerit Medical Systems, Inc.PYC2023-08-12
50197106328901CARDINAL HEALTHCardinal Health 200, LLCPYC2023-08-09
50197106328802CARDINAL HEALTHCardinal Health 200, LLCPYC2023-08-02
50197106328888CARDINAL HEALTHCardinal Health 200, LLCPYC2023-08-02
50197106328963CARDINAL HEALTHCardinal Health 200, LLCPYC2023-07-25
50197106326921CARDINAL HEALTHCardinal Health 200, LLCPYC2023-07-12
50197106328819CARDINAL HEALTHCardinal Health 200, LLCPYC2023-07-05
50197106328932CARDINAL HEALTHCardinal Health 200, LLCPYC2023-07-05
50197106328826CARDINAL HEALTHCardinal Health 200, LLCPYC2023-07-03
50197106328796CARDINAL HEALTHCardinal Health 200, LLCPYC2023-06-26
50197106328949CARDINAL HEALTHCardinal Health 200, LLCPYC2023-06-26
50197106328918CARDINAL HEALTHCardinal Health 200, LLCPYC2023-06-16
50197106259168CARDINAL HEALTHCardinal Health 200, LLCPYC2023-05-18
50197106152889CARDINAL HEALTHCardinal Health 200, LLCPYC2023-03-30
50197106098385CARDINAL HEALTHCardinal Health 200, LLCPYC2023-02-01