FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106362998
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEROCDTWRA
Catalog number
SEROCDTWRA
Device description
DRAINAGE TRAY
Published
2023-07-31
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
PXUFluid drainage tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PXUFluid Drainage TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106362998PackageGS12In Commercial Distribution
10197106362990PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710636299850197106362998
1019710636299010197106362990

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
10192253033502Monoject118030055511803005552022-10-21
10630140029332CONVERTORS29459294592016-06-28
10630140031403CONVERTORS29461294612016-06-28
10885380026577CONVERTORS29435294352016-06-28
10885380034862CONVERTORS74210742102016-06-28
10885380038075CONVERTORS29520295202016-06-28
10885380053740CONVERTORS29456294562016-06-22
10885380058134CONVERTORSD1062D10622016-06-29
10885380058387CONVERTORS945094502016-06-28
10885380062278CONVERTORS944494442016-06-22
10885380062285CONVERTORS755475542016-06-28
10885380062308CONVERTORS955695562016-07-08
10885380063664CONVERTORS29452294522016-06-28
10885380071539CONVERTORS956295622016-07-13
10885380071652CONVERTORS29417294172016-06-28
10885380071690CONVERTORS29458294582016-06-28
10885380108624CONVERTORS29430294302016-06-22
10885380108648CONVERTORS29447294472016-06-22
10885380108655CONVERTORS29448294482016-06-22
10885380108662CONVERTORS29449294492016-06-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05708265018024LiNA OperaScope™ Tubing & Drape kitLiNA Medical AGPXU2026-04-03
04046955911493ASEPTB. BRAUN MEDICAL INC.PXU2025-10-14
10198956062894CARDINAL HEALTHCardinal Health 200, LLCPXU2025-05-02
50198956062892CARDINAL HEALTHCardinal Health 200, LLCPXU2025-05-02
10197106485897CARDINAL HEALTHCardinal Health 200, LLCPXU2023-12-27
50197106485895CARDINAL HEALTHCardinal Health 200, LLCPXU2023-12-27
00884450727911Merit Medical®Merit Medical Systems, Inc.PXU2023-11-08
00884450727928Merit Medical®Merit Medical Systems, Inc.PXU2023-11-08
10884450727918Merit Medical®Merit Medical Systems, Inc.PXU2023-11-08
10884450727925Merit Medical®Merit Medical Systems, Inc.PXU2023-11-08
10197106328750CARDINAL HEALTHCardinal Health 200, LLCPXU2023-10-12
50197106328758CARDINAL HEALTHCardinal Health 200, LLCPXU2023-10-12
10197106362990CARDINAL HEALTHCardinal Health 200, LLCPXU2023-07-31
10197106323458CARDINAL HEALTHCardinal Health 200, LLCPXU2023-07-06
50197106323456CARDINAL HEALTHCardinal Health 200, LLCPXU2023-07-06
10195594830410CARDINAL HEALTHCardinal Health 200, LLCPXU2022-09-14
50195594830418CARDINAL HEALTHCardinal Health 200, LLCPXU2022-09-14
00860003054949CLR MedicalCLR MedicalPXU2021-11-05
10195594131883CARDINAL HEALTHCardinal Health 200, LLCPXU2021-06-01
50195594131881CARDINAL HEALTHCardinal Health 200, LLCPXU2021-06-01
00884450486061PeriVac™ KitMerit Medical Systems, Inc.PXU2020-12-22
00884450486115PeriVac™ KitMerit Medical Systems, Inc.PXU2020-12-22
10884450486068Merit Medical®Merit Medical Systems, Inc.PXU2020-12-22
10884450486112Merit Medical®Merit Medical Systems, Inc.PXU2020-12-22
05708265012480LiNA OperaScope™ Tubing & Drape kitLina Medical ApSPXU2020-09-04
10888439581379CARDINAL HEALTHCardinal Health 200, LLCPXU2019-09-09
50888439581377CARDINAL HEALTHCardinal Health 200, LLCPXU2019-09-09
10888439448160CARDINAL HEALTHCardinal Health 200, LLCPXU2019-04-29
50888439448168CARDINAL HEALTHCardinal Health 200, LLCPXU2019-04-29
04046955237500ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCPXU2019-04-26