FDA.reportPublic FDA data

Aero-Med

Primary DI
00810010892218
Brand
Aero-Med
Company
AERO-MED, LLC
Model
AMM930
Catalog number
AMM930
Device description
KIT, URINE TRANSFER STRAW
Published
2019-06-27
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
50810010892213PackageGS1100In Commercial Distribution
00810010892218PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5081001089221350810010892213
00810010892218008100108922188100108922180810010892218

GMDN Terms#

Term, Definition table
TermDefinition
Urine specimen collection kit IVDA collection of noninvasive devices intended to be used for the collection, preservation, and transport of a urine specimen for culture, analysis, and/or other investigation. It typically consists of a primary urine collection receptacle (e.g., cup, conical tube, vessel), a urine preservation/transport tube [typically evacuated, with or without additives], and a transfer device for facilitating the aseptic transfer of a urine sample between receptacles; supportive devices for urine collection (e.g., wet wipes, absorbent pads, Foley catheter connector) and/or analysis [e.g., microscope slides, tube rack] may also be included in the kit. 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
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885380214516Aero-MedCA62475ACA62475A2026-10-19
10885380213908Aero-MedCA52100ACA52100A2026-09-25
10885380169762Aero-MedCA22975CA229752019-03-08
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885380214516Aero-MedAERO-MED, LLCOIB2026-10-19
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