FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50885380155367
Brand
CARDINAL HEALTH
Company
Aero-Med, Ltd.
Model
CA15375
Catalog number
CA15375
Device description
Specimen Transport Kits, UAB Only
Published
2017-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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
50885380155367PackageGS112In Commercial Distribution
10885380155369PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088538015536750885380155367
1088538015536910885380155369

GMDN Terms#

Term, Definition table
TermDefinition
General specimen receptacle transport containerA non-powered portable device designed for the transportation of clinical specimens contained within receptacles (e.g., glass vials, bottles, tubes, slides, swabs) from the point of collection to the laboratory or between medical institutions. It is typically designed to be liquid-tight with a shock-absorbing foam liner to protect the contents from adverse conditions that could cause breakage and to absorb any escaped fluid. It is available in a variety of designs whereby it may be thermally insulated and might include a non-powered cold pack(s). This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
194550042
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
50192253068748Aero-MedCA38075BCA38075B2025-05-01
50885380208308Aero-MedCA1500ACA1500A2025-04-18
50885380183667Aero-MedCA18750ACA18750A2025-04-15
50885380207721Aero-MedCA18725BCA18725B2025-04-15
50810010894729Aero-MedQUE3325QUE33252025-04-10
50885380207707Aero-MedCA38075BCA38075B2025-04-08
50885380207714Aero-MedCA38100BCA38100B2025-04-08
50885380208063Aero-MedCA14800BCA14800B2025-04-07
50885380198715Aero-MedCA54550CA545502024-01-08
50885380207745Aero-MedCA61875CA618752025-04-02
50885380198708Aero-MedCA32250BCA32250B2024-01-08
50885380207455Aero-MedCA61175CA611752025-03-20
50885380207677Aero-MedCA61900CA619002025-03-19
50810010894774Aero-MedAMM19300AMM193002025-03-06
50885380207363Aero-MedCA59025CA590252025-03-03
50885380207448Aero-MedCA59000CA590002025-03-03
50810010894736Aero-MedAMM18850AMM188502025-02-11
50810010894743Aero-MedAMM18875AMM188752025-02-11
50885380205536Aero-MedCA60225CA602252024-10-07
50885380206823Aero-MedCA60675CA606752025-01-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810057230448SNT BiotechSARIS AND THINGS, INC.OIB2026-06-04
10885380212017Aero-MedAERO-MED, LLCOIB2026-06-04
10885380212024Aero-MedAERO-MED, LLCOIB2026-06-04
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
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