FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594427795
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA30UNRA4
Catalog number
SBA30UNRA4
Device description
UNIVERSAL PACK NO MAYO
Published
2021-11-12
Public version status
Update
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
PPDUniversal drainage tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPDUniversal Drainage TrayGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594427793PackageGS16In Commercial Distribution
10195594427795PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559442779350195594427793
1019559442779510195594427795

GMDN Terms#

Term, Definition table
TermDefinition
Urological surgical procedure kit, non-medicated, single-useA collection of various urological surgical instruments and the necessary materials intended to be used during a urological surgical/endoscopic procedure; it is not a dedicated bladder irrigation set. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of urological surgical procedure, but are often supplied together to perform a specific type of urological procedure; it does not contain any pharmaceuticals. This is a single-use device.

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
10198956232792CARDINAL HEALTHSOP3IOLUTASOP3IOLUTA2026-07-16
10198956260016CARDINAL HEALTHSNE23SPMABSNE23SPMAB2026-07-16
10198956319929CARDINAL HEALTHSAN55TPKFCSAN55TPKFC2026-07-16
10198956326484CARDINAL HEALTH03-1708O03-1708O2026-07-16
10198956334342CARDINAL HEALTHPO21FKEGBPO21FKEGB2026-07-16
10198956335523CARDINAL HEALTHSAN19CCKHOSAN19CCKHO2026-07-16
10198956344020CARDINAL HEALTHSCV73OPBHCSCV73OPBHC2026-07-16
10198956359611CARDINAL HEALTHPO24ARSMCPO24ARSMC2026-07-16
10198956360112CARDINAL HEALTHSMA55DPKCSSMA55DPKCS2026-07-16
10198956364837CARDINAL HEALTHPO54KTGCCPO54KTGCC2026-07-16
10198956368002CARDINAL HEALTHSOPHDUPUBDSOPHDUPUBD2026-07-16
10198956382381CARDINAL HEALTHSCV5DPPUMDSCV5DPPUMD2026-07-16
10198956382930CARDINAL HEALTHSEY48CPOELSEY48CPOEL2026-07-16
10198956388178CARDINAL HEALTHSENHDTAHGDSENHDTAHGD2026-07-16
10198956390546CARDINAL HEALTHSEYHDEYSPBSEYHDEYSPB2026-07-16
10198956392755CARDINAL HEALTHSOPOCPPAEBSOPOCPPAEB2026-07-16
10198956395886CARDINAL HEALTHSAN53EPVSFSAN53EPVSF2026-07-16
10198956400856CARDINAL HEALTH08-0077C08-0077C2026-07-16
10198956408401CARDINAL HEALTHSOPVXEXBMESOPVXEXBME2026-07-16
10198956418431CARDINAL HEALTHSAN69BPKIBSAN69BPKIB2026-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450434482Merit Medical®Merit Medical Systems, Inc.PPD2026-07-14
00884450492956Merit Medical®Merit Medical Systems, Inc.PPD2026-07-11
00884450467039Merit Medical®Merit Medical Systems, Inc.PPD2026-07-07
00884450438480Merit Medical®Merit Medical Systems, Inc.PPD2026-07-03
00884450486337Merit Medical®Merit Medical Systems, Inc.PPD2026-07-03
00884450436202Merit Medical®Merit Medical Systems, Inc.PPD2026-06-25
00884450383896Merit Medical®Merit Medical Systems, Inc.PPD2026-06-24
00884450486993Merit Medical®Merit Medical Systems, Inc.PPD2026-06-09
00884450110270Merit Drainage Depot™Merit Medical Systems, Inc.PPD2026-06-06
00884450467183Merit Medical®Merit Medical Systems, Inc.PPD2026-06-02
00884450487679Merit Medical®Merit Medical Systems, Inc.PPD2026-05-28
00884450111185Merit Medical®Merit Medical Systems, Inc.PPD2026-05-02
10198956325166CARDINAL HEALTHCardinal Health 200, LLCPPD2026-03-10
00884450112120Merit Medical®Merit Medical Systems, Inc.PPD2026-02-25
00884450111109Merit Medical®Merit Medical Systems, Inc.PPD2026-02-20
00884450111857Merit Medical®Merit Medical Systems, Inc.PPD2026-02-14
00884450112090Merit Medical®Merit Medical Systems, Inc.PPD2026-02-05
00884450112540Merit Medical®Merit Medical Systems, Inc.PPD2026-01-27
00884450113240Merit Medical®Merit Medical Systems, Inc.PPD2026-01-20
00884450112267Merit Medical®Merit Medical Systems, Inc.PPD2026-01-03
00884450113479Merit Medical®Merit Medical Systems, Inc.PPD2026-01-03
00884450034002Merit Medical®Merit Medical Systems, Inc.PPD2025-12-18
00884450108758Merit Medical®Merit Medical Systems, Inc.PPD2025-12-18
00884450110546Merit Medical®Merit Medical Systems, Inc.PPD2025-12-18
00884450108499Merit Medical®Merit Medical Systems, Inc.PPD2025-12-16
00884450110782Waste Management KitMerit Medical Systems, Inc.PPD2025-12-12
00884450113509Merit Medical®Merit Medical Systems, Inc.PPD2025-12-12
00884450105474Merit Medical®Merit Medical Systems, Inc.PPD2025-11-27
00884450105849Merit Medical®Merit Medical Systems, Inc.PPD2025-11-27
00884450034057Merit Medical®Merit Medical Systems, Inc.PPD2025-11-22