FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50888439976890
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
39-9971B
Catalog number
39-9971B
Device description
VAGINAL PREP TRAY
Published
2023-02-17
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
OJUSkin prep tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJUSkin Prep TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50888439976890PackageGS14In Commercial Distribution
10888439976892PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843997689050888439976890
1088843997689210888439976892

GMDN Terms#

Term, Definition table
TermDefinition
Tracheostomy care kit, single-useA collection of sterile devices and supplies intended to be used for the maintenance of a tracheostomy (i.e., removal and cleaning of tracheostomy tube prior to reinsertion). It typically includes towels, gauze, swabs, cleaning brush, and gloves. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature040 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
10885380184895CARDINAL HEALTH82021820212024-07-25
10885380184901CARDINAL HEALTH82022820222024-07-25
10885380184918CARDINAL HEALTH82023820232024-07-25
10885380184925CARDINAL HEALTH82024820242024-07-25
50885380004818CONVERTORS9423N9423N2016-06-21
50885380009837CONVERTORS29455NA29455NA2016-06-21
50885380016972CONVERTORS29557N29557N2016-06-21
50885380020016CONVERTORS9450N9450N2016-06-21
50885380027916CONVERTORS9441N9441N2016-06-21
50885380030619CONVERTORS29444N29444N2016-06-21
50885380034068CONVERTORS29527N29527N2016-06-21
50885380034402CONVERTORS29559N29559N2016-06-21
50885380036116CONVERTORS9449N9449N2016-06-21
50885380053755CONVERTORS29421NB29421NB2016-06-21
50885380053779CONVERTORS9438NB9438NB2016-06-21
50885380053854CONVERTORS29465NB29465NB2016-06-21
50885380053878CONVERTORS29467NB29467NB2016-06-21
50885380053892CONVERTORS29522NB29522NB2016-06-21
50885380053922CONVERTORS9430NB9430NB2016-06-21
50885380053939CONVERTORS9458NB9458NB2016-06-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10195327428433Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-12-21
10195327435981Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-08-20
10195327242664Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-07-29
10195327261627Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-07-29
10195327421830Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-07-29
10195327427382Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-07-29
10195327428228Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-07-29
10195327432614Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-07-29
10195327440282Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-07-23
10195327437534Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-25
10195327439620Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-25
10195327238445Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13
10195327267025Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13
10195327268046Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13
10195327269197Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13
10195327272012Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13
10195327272555Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13
10195327277093Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13
10195327277284Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13
10195327277925Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13
10195327278922Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13
10195327279004Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13
10195327280567Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13
10195327285517Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13
10195327285654Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13
10195327297602Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13
10195327298753Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13
10195327340643Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13
10195327342722Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13
10195327343163Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJU2023-06-13