FDA.reportPublic FDA data

Aero-Med

Primary DI
20885380206174
Brand
Aero-Med
Company
Aero-Med, Ltd.
Model
CA59875
Catalog number
CA59875
Device description
Kit Blood Collection for Southern Research Only
Published
2024-12-13
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
20885380206174PackageGS11In Commercial Distribution
50885380206175PackageGS14In Commercial Distribution
10885380206177PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088538020617420885380206174
5088538020617550885380206175
1088538020617710885380206177

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
194550042
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
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
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
10885380213908Aero-MedAERO-MED, LLCOIB2026-09-25
10885380213922Aero-MedAERO-MED, LLCOIB2026-09-25