FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106328798
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
30-CE8COA
Catalog number
30-CE8COA
Device description
THORA PARA CATHETER DRAINAGE
Published
2023-06-26
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
50197106328796PackageGS110In Commercial Distribution
10197106328798PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710632879650197106328796
1019710632879810197106328798

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
10192253072037CARDINAL HEALTHALMASK5ALMASK52026-07-29
10192253072044CARDINAL HEALTHAMMASK4AMMASK42026-07-29
10192253072051CARDINAL HEALTHAXLMASK6AXLMASK62026-07-29
10192253072068CARDINAL HEALTHCHIMASK3CHIMASK32026-07-29
10192253072075CARDINAL HEALTHINFMASK1INFMASK12026-07-29
10192253072082CARDINAL HEALTHNEOMASK0NEOMASK02026-07-29
10192253072105CARDINAL HEALTHTODMASK2TODMASK22026-07-29
10192253025699Dover888876051688887605162023-11-21
10192253025705Dover888876051888887605182023-11-21
10192253025712Dover888876052088887605202023-11-21
10192253025750Dover888876301888887630182023-11-21
10192253025774Dover888876302288887630222023-11-21
10192253026344Dover35603560-2022-04-12
10192253028201Dover62086208-2024-10-14
10192253030365Dover888849206688884920662025-04-07
10192253031836DoverP4P16ULDP4P16ULD-2024-08-22
10192253068573Dover33053305-2026-01-16
10192253068634Dover61556155-2026-01-16
10197106541029CARDINAL HEALTH01A1360C01A1360C2024-03-06
10197106741030CARDINAL HEALTH03-2242D03-2242D2024-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956489035CARDINAL HEALTHCardinal Health 200, LLCPYC2026-06-05
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