FDA.reportPublic FDA data

Aero-Med

Primary DI
10885380177019
Brand
Aero-Med
Company
AERO-MED, LLC
Model
CA26775
Catalog number
CA26775
Device description
24 Hour UA Mail Back Kit, Mayo Clinic Scottsdale
Published
2020-02-04
Public version status
Update
Distribution status
Not 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
50885380177017PackageGS14Not in Commercial Distribution
10885380177019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088538017701750885380177017
1088538017701910885380177019

GMDN Terms#

Term, Definition table
TermDefinition
Faecal specimen collection kit IVD, home-useA collection of devices and materials intended to be used by a layperson in the home to self-collect a faecal (stool) sample for subsequent in vitro diagnostic testing or screening purposes (e.g., occult blood, cytology) in a clinical laboratory. The kit may consist of a specimen container(s) with or without an additive/medium (e.g., cell or nucleic acid preservative solution, Carey-Blair transport medium), collection assistive device(s) (e.g., blush, spatula), gloves, labels, and/or a return packing/envelope for submission/mailing to the clinical laboratory. This is a single-use device.

Regulatory Flags#

DUNS number
194550042
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885380213960Aero-MedCA63825CA638252026-10-07
10885380213953Aero-MedCA65375CA653752026-10-06
10885380195839Aero-MedCA2300BCA2300B2023-06-14
10885380193002Aero-MedCA30725CA307252026-09-29
10192253061093Aero-MedCA39450CA394502026-02-20
10885380182808Aero-MedCA29150CA291502020-11-02
10192253057591Aero-MedCA40000CA400002026-09-28
10192253063226Aero-MedCA42700ACA42700A2026-09-28
10192253063332Aero-MedCA44925CA449252026-09-28
10192253066760Aero-MedCA39525ACA39525A2026-09-28
10192253067644Aero-MedCA61050CA610502026-09-28
10885380185045Aero-MedCA37600CA376002026-09-28
10885380185052Aero-MedCA37575CA375752026-09-28
10885380187889Aero-MedCA39325CA393252026-09-28
10885380190261Aero-MedCA41500CA415002026-09-28
10885380190988Aero-MedCA42025CA420252026-09-28
10885380195822Aero-MedCA46425CA464252026-09-28
10885380196812Aero-MedCA50450CA504502026-09-28
10885380196829Aero-MedCA50600CA506002026-09-28
10885380200601Aero-MedCA56375CA563752026-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885380213960Aero-MedAERO-MED, LLCOIB2026-10-07
10885380213953Aero-MedAERO-MED, LLCOIB2026-10-06
10885380193002Aero-MedAERO-MED, LLCOIB2026-09-29
10192253057591Aero-MedAERO-MED, LLCOIB2026-09-28
10192253063226Aero-MedAERO-MED, LLCOIB2026-09-28
10192253063332Aero-MedAERO-MED, LLCOIB2026-09-28
10192253066760Aero-MedAERO-MED, LLCOIB2026-09-28
10192253067644Aero-MedAERO-MED, LLCOIB2026-09-28
10885380185045Aero-MedAERO-MED, LLCOIB2026-09-28
10885380185052Aero-MedAERO-MED, LLCOIB2026-09-28
10885380187889Aero-MedAERO-MED, LLCOIB2026-09-28
10885380190261Aero-MedAERO-MED, LLCOIB2026-09-28
10885380190988Aero-MedAERO-MED, LLCOIB2026-09-28
10885380195822Aero-MedAERO-MED, LLCOIB2026-09-28
10885380196812Aero-MedAERO-MED, LLCOIB2026-09-28
10885380196829Aero-MedAERO-MED, LLCOIB2026-09-28
10885380200601Aero-MedAERO-MED, LLCOIB2026-09-28
10885380200823Aero-MedAERO-MED, LLCOIB2026-09-28
10885380200830Aero-MedAERO-MED, LLCOIB2026-09-28
10885380200892Aero-MedAERO-MED, LLCOIB2026-09-28
10885380202841Aero-MedAERO-MED, LLCOIB2026-09-28
10885380203169Aero-MedAERO-MED, LLCOIB2026-09-28
10885380206559Aero-MedAERO-MED, LLCOIB2026-09-28
10885380206566Aero-MedAERO-MED, LLCOIB2026-09-28
10885380206573Aero-MedAERO-MED, LLCOIB2026-09-28
10885380206580Aero-MedAERO-MED, LLCOIB2026-09-28
10885380206597Aero-MedAERO-MED, LLCOIB2026-09-28
10885380207662Aero-MedAERO-MED, LLCOIB2026-09-28
10885380208836Aero-MedAERO-MED, LLCOIB2026-09-28
10885380213939Aero-MedAERO-MED, LLCOIB2026-09-28