FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10810010891225
Brand
CARDINAL HEALTH
Company
AERO-MED, LLC
Model
AMM999
Catalog number
AMM999
Device description
Urine Foley Catheter Kit
Published
2019-04-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
OIBBlood and urine collection kit (excludes HIV testing)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OIBBlood And Urine Collection Kit (Excludes Hiv Testing)Pathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50810010891223PackageGS1100In Commercial Distribution
10810010891225PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5081001089122350810010891223
1081001089122510810010891225

GMDN Terms#

Term, Definition table
TermDefinition
Urine specimen collection kit IVDA collection of noninvasive devices intended to be used for the collection, preservation, and transport of a urine specimen for culture, analysis, and/or other investigation. It typically consists of a primary urine collection receptacle (e.g., cup, conical tube, vessel), a urine preservation/transport tube [typically evacuated, with or without additives], and a transfer device for facilitating the aseptic transfer of a urine sample between receptacles; supportive devices for urine collection (e.g., wet wipes, absorbent pads, Foley catheter connector) and/or analysis [e.g., microscope slides, tube rack] may also be included in the kit. This is a single-use device.

Regulatory Flags#

DUNS number
194550042
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810010891140CARDINAL HEALTHAMM542AMM5422019-04-26
00810010894991Aero-MedAMM10475AAMM10475A2026-04-07
00810010895004Aero-MedAMM12325AAMM12325A2026-04-07
10810010890990CARDINAL HEALTHFO2FO22019-04-26
10810010891027CARDINAL HEALTHAMM070AMM0702019-04-26
10810010891034CARDINAL HEALTHAMM080AMM0802019-04-26
10810010891041CARDINAL HEALTHAMM215AMM2152019-04-26
10810010891119CARDINAL HEALTHAMM521AMM5212019-04-26
10810010891164CARDINAL HEALTHAMM552AMM5522019-04-26
10810010891171CARDINAL HEALTHAMM579AMM5792019-04-26
10810010891232CARDINAL HEALTHAMM1550AMM15502019-04-26
10810010891263CARDINAL HEALTHAMM1800AMM18002019-04-26
10810010891270CARDINAL HEALTHAMM1875AMM18752019-04-26
10810010891287CARDINAL HEALTHAMM1925AMM19252019-04-26
10810010891546CARDINAL HEALTHHHC100HHC1002019-04-26
10810010891294CARDINAL HEALTHAMM1950AMM19502019-04-26
10810010891300CARDINAL HEALTHAMM1951AMM19512019-04-26
10810010891317CARDINAL HEALTHAMM1952AMM19522019-04-26
10810010891324CARDINAL HEALTHAMM1953AMM19532019-04-26
10810010891331CARDINAL HEALTHAMM1954AMM19542019-04-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253071504Aero-MedAERO-MED, LLCOIB2026-04-16
10192253061031Aero-MedAERO-MED, LLCOIB2026-02-20
10192253061093Aero-MedAERO-MED, LLCOIB2026-02-20
10192253061109Aero-MedAERO-MED, LLCOIB2026-02-20
10192253061475Aero-MedAERO-MED, LLCOIB2026-02-20
10192253061482Aero-MedAERO-MED, LLCOIB2026-02-20
10192253061505Aero-MedAERO-MED, LLCOIB2026-02-20
10194717120087Regard™ROI CPS, LLCOIB2024-10-02
10194717119739Regard™ROI CPS, LLCOIB2024-07-19
10194717119449Regard™ROI CPS, LLCOIB2024-05-21
10195327338220Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OIB2023-12-21
10192253064650Aero-MedAERO-MED, LLCOIB2023-11-15
10194717117865Regard™ROI CPS, LLCOIB2023-11-09
10192253064001Aero-MedAERO-MED, LLCOIB2023-10-12
10192253064018Aero-MedAERO-MED, LLCOIB2023-10-12
10194717117834Regard™ROI CPS, LLCOIB2023-09-29
10192253064346Aero-MedAERO-MED, LLCOIB2023-09-25
10192253064339CARDINAL HEALTHAERO-MED, LLCOIB2023-08-24
10195327228576Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OIB2023-06-13
10195327256647Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OIB2023-06-13
10195327281359Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OIB2023-06-13
10195327344672Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OIB2023-06-13
10195327345808Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OIB2023-06-13
10195327347550Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OIB2023-06-13
10195327356163Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OIB2023-06-13
10195327365479Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OIB2023-06-13
10195327264833Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OIB2023-06-08
10195327265120Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OIB2023-06-08
10195327282462Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OIB2023-04-23
10195327353490Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OIB2023-04-23