FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106914203
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
30-7478R
Catalog number
30-7478R
Device description
PARACENTESIS TRAY
Published
2025-02-17
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
50197106914203PackageGS110In Commercial Distribution
10197106914205PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710691420350197106914203
1019710691420510197106914205

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450277652Safety Paracentesis Procedure TrayMerit Medical Systems, Inc.PYC2026-09-22
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
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