FDA.reportPublic FDA data

Aero-Med

Primary DI
50885380130180
Brand
Aero-Med
Company
Aero-Med, Ltd.
Model
CA7725
Catalog number
CA7725
Device description
LAB KIT, CAP REPACK, SOUTHWEST LAB
Published
2019-04-12
Public version status
New
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
50885380130180PackageGS1100In Commercial Distribution
20885380130189PrimaryGS10
10885380130182Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088538013018050885380130180
2088538013018920885380130189
1088538013018210885380130182

GMDN Terms#

Term, Definition table
TermDefinition
Phlebotomy kitA collection of devices and supplies used in the practice of collecting blood samples. It typically consists of test tubes, racks, needles, bandages, gauze pads, and a sharps container. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
194550042
Device count
100
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
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