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
10198956428201CARDINAL HEALTH26-2755C26-2755C2026-10-01
10198956512474CARDINAL HEALTH28A5420I28A5420I2026-10-01
10198956524316CARDINAL HEALTH34A5387R34A5387R2026-10-01
10198956537385CARDINAL HEALTH28-6325B28-6325B2026-10-01
10198956563087CARDINAL HEALTH34-2454E34-2454E2026-10-01
10198956587298CARDINAL HEALTH40-6487C40-6487C2026-10-01
10885380214714Curity8441368441362026-09-30
10885380214738Curity8441568441562026-09-30
10885380214707Curity8441268441262026-09-28
10885380214721Curity8441468441462026-09-28
10885380214745Curity8441668441662026-09-28
10885380214752Curity8441768441762026-09-28
10885380214769Curity8442168442162026-09-28
10885380214776Curity8442268442262026-09-28
10885380214783Curity8442368442362026-09-28
10885380214790Curity8442468442462026-09-28
10885380214806Curity8442568442562026-09-28
20192253017561Medi-Trace Cadence22660P22660P2024-02-28
20192253017608Medi-Trace Cadence22660R22660R-2024-02-28
50885380050365CARDINAL HEALTHCA901CHCA901CH2021-06-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450428016Merit Medical®Merit Medical Systems, Inc.PPD2026-09-22
00884450437810Merit Medical®Merit Medical Systems, Inc.PPD2026-09-19
00884450320150Merit Medical®Merit Medical Systems, Inc.PPD2026-09-18
00884450320426Merit Medical®Merit Medical Systems, Inc.PPD2026-09-18
00884450428443Merit Medical®Merit Medical Systems, Inc.PPD2026-09-18
00884450428474Merit Medical®Merit Medical Systems, Inc.PPD2026-08-19
00884450432365Merit Medical®Merit Medical Systems, Inc.PPD2026-08-18
00884450428245Merit Medical®Merit Medical Systems, Inc.PPD2026-08-15
00884450488775Merit Medical®Merit Medical Systems, Inc.PPD2026-08-14
00884450499207Merit Medical®Merit Medical Systems, Inc.PPD2026-07-30
00884450383865Merit Medical®Merit Medical Systems, Inc.PPD2026-07-25
00884450431764Merit Medical®Merit Medical Systems, Inc.PPD2026-07-22
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