FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50195594427793
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
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
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 sterile urological surgical instruments and the necessary materials intended to be used to perform a urological surgical procedure. 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.

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
10884450425333Merit Medical®Merit Medical Systems, Inc.PPD2026-03-24
10884450430788Merit Medical®Merit Medical Systems, Inc.PPD2026-03-21
10884450457822Merit Medical®Merit Medical Systems, Inc.PPD2026-03-21
10884450429942Merit Medical®Merit Medical Systems, Inc.PPD2026-03-13
10884450431204Merit Medical®Merit Medical Systems, Inc.PPD2026-03-13
10884450441487Merit Medical®Merit Medical Systems, Inc.PPD2026-03-13
20884450431270Merit Medical®Merit Medical Systems, Inc.PPD2026-03-12
10884450431365Merit Medical®Merit Medical Systems, Inc.PPD2026-03-12
10884450435363Merit Medical®Merit Medical Systems, Inc.PPD2026-03-12
20884450437524Merit Medical®Merit Medical Systems, Inc.PPD2026-03-12
20884450428775Merit Medical®Merit Medical Systems, Inc.PPD2026-03-10
50198956325164CARDINAL HEALTHCardinal Health 200, LLCPPD2026-03-10
20884450441934Merit Medical®Merit Medical Systems, Inc.PPD2026-03-05
10884450436353Merit Medical®Merit Medical Systems, Inc.PPD2026-03-03
10884450383886Merit Medical®Merit Medical Systems, Inc.PPD2026-02-28
20884450428744Merit Medical®Merit Medical Systems, Inc.PPD2026-02-28
20884450435414Merit Medical®Merit Medical Systems, Inc.PPD2026-02-26
20884450112124Merit Medical®Merit Medical Systems, Inc.PPD2026-02-25
20884450385627Merit Medical®Merit Medical Systems, Inc.PPD2026-02-21
20884450111103Merit Medical®Merit Medical Systems, Inc.PPD2026-02-20
20884450111851Merit Medical®Merit Medical Systems, Inc.PPD2026-02-14
10884450433680Waste Management KitMerit Medical Systems, Inc.PPD2026-02-14
00884450451601Merit Medical®Merit Medical Systems, Inc.PPD2026-02-07
00884450410776Merit Medical®Merit Medical Systems, Inc.PPD2026-02-06
10884450112097Merit Medical®Merit Medical Systems, Inc.PPD2026-02-05
20884450436398Merit Medical®Merit Medical Systems, Inc.PPD2026-01-29
20884450112544Merit Medical®Merit Medical Systems, Inc.PPD2026-01-27
20884450383906Merit Medical®Merit Medical Systems, Inc.PPD2026-01-27
10884450209308Merit Medical®Merit Medical Systems, Inc.PPD2026-01-23
20884450428614Merit Medical®Merit Medical Systems, Inc.PPD2026-01-22