FDA.reportPublic FDA data

Aero-Med

Primary DI
00810010893000
Brand
Aero-Med
Company
AERO-MED, LLC
Model
AMM4175
Catalog number
AMM4175
Device description
Blood Collection Kit
Published
2021-01-06
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
50810010893005PackageGS112In Commercial Distribution
00810010893000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5081001089300550810010893005
00810010893000008100108930008100108930000810010893000

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.

Regulatory Flags#

DUNS number
194550042
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885380213908Aero-MedCA52100ACA52100A2026-09-25
10885380213922Aero-MedCA65350CA653502026-09-25
00810010894687Aero-MedAMM18150AMM181502026-09-24
10885380122057CARDINAL HEALTHCA1475CA14752019-04-12
10885380184376Aero-MedCA3100ACA3100A2021-02-24
10885380187902Aero-MedCA38275CA382752026-02-20
10885380189159Aero-MedCA36975CA369752026-02-20
10885380194733Aero-MedCA48325CA483252023-02-24
10885380195365Aero-MedCA49825CA498252023-04-20
10885380202605Aero-MedCA42225ACA42225A2024-05-10
10885380205217Aero-MedCA54650ACA54650A2024-08-28
10885380208515Aero-MedCA6000BCA6000B2025-06-19
10885380211195Aero-MedCA19925ACA19925A2026-02-13
10885380211218Aero-MedCA7225ACA7225A2026-03-20
10885380175237Aero-MedCA23450CA234502019-10-07
10885380199165Aero-MedCA52075CA520752024-01-31
10885380210891Aero-MedCA62250CA622502026-06-10
10885380213465Aero-MedCA64850CA648502026-06-10
10192253062595Aero-MedCA28600ACA28600A2022-08-26
10192253062601Aero-MedCA37125CA371252022-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885380213908Aero-MedAERO-MED, LLCOIB2026-09-25
10885380213922Aero-MedAERO-MED, LLCOIB2026-09-25
00810010894687Aero-MedAERO-MED, LLCOIB2026-09-24
00810111410533LetsGetChecked Blood and Urine Sample Collection Kit (ST04)PRIVAPATH DIAGNOSTICS LIMITEDOIB2026-08-07
00810111410601LetsGetChecked Blood and Urine Sample Collection Kit (CKDRN2 & GLCSKED)PRIVAPATH DIAGNOSTICS LIMITEDOIB2026-08-07
00810111410663LetsGetChecked Blood and Urine Sample Collection Kit (KDB1 & KDB2)PRIVAPATH DIAGNOSTICS LIMITEDOIB2026-08-07
00810111410724LetsGetChecked Blood and Urine Sample Collection Kit (CM08B & CM08C)PRIVAPATH DIAGNOSTICS LIMITEDOIB2026-08-07
00810111410809LetsGetChecked Blood and Urine Sample Collection Kit (ST05)PRIVAPATH DIAGNOSTICS LIMITEDOIB2026-08-07
10885380210891Aero-MedAERO-MED, LLCOIB2026-06-10
10885380213465Aero-MedAERO-MED, LLCOIB2026-06-10
00810057230448SNT BiotechSARIS AND THINGS, INC.OIB2026-06-04
10885380212017Aero-MedAERO-MED, LLCOIB2026-06-04
10885380212024Aero-MedAERO-MED, LLCOIB2026-06-04
10885380211768Aero-MedAERO-MED, LLCOIB2026-05-06
10192253071504Aero-MedAERO-MED, LLCOIB2026-04-16
10885380211218Aero-MedAERO-MED, LLCOIB2026-03-20
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
10885380211188Aero-MedAERO-MED, LLCOIB2026-02-13
10885380210921Aero-MedAERO-MED, LLCOIB2026-01-20
10885380210938Aero-MedAERO-MED, LLCOIB2026-01-20
10885380210877Aero-MedAERO-MED, LLCOIB2025-12-26
10885380208935Aero-MedAERO-MED, LLCOIB2025-11-04
10885380209222Aero-MedAERO-MED, LLCOIB2025-08-26
10885380208928Aero-MedAERO-MED, LLCOIB2025-08-21
10885380208447Aero-MedAERO-MED, LLCOIB2025-06-10