Aero-Med - ED Urine Collection Kit for UNC Health Only
2026-09-25
AERO-MED LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3006191977 | 3006191977 | AERO-MED LLC | 1 | N | 2026-01-01 | 65 Olde Roberts St East Hartford CT US 06108 |
| 3012355620 | 3012355620 | Aero-Med Ltd | 1 | N | 2020-04-25 | 5110 W 74th St Building 97 Indianapolis IN US 46268 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 188083 | 1173586416 | K983952 | GREINER VACUETTE BLOOD COLLECTION TUBE | JKA | 1998-12-28 |
| 188083 | 1992835261 | K971849 | CYTOLOGY BRUSH | HHT | 1997-07-24 |
| 188083 | 1109136821 | K945952 | VACUTAINER(R) BRAND PLUS PST(TM) PLASMA SEPARATION TUBE | JKA | 1995-01-18 |
| 188083 | 1335499454 | K930955 | CERVEX-BRUSH | HHT | 1994-05-24 |
| 188083 | 1857696925 | K896065 | WALLACH CC/BRUSH | HHT | 1990-01-04 |
| 188083 | 1354923371 | K861389 | PAP SMEAR KIT | HHT | 1986-05-02 |
| 188083 | 1497052047 | K832986 | PAP SMEAR BRUSH | HHT | 1984-02-10 |
| 188083 | 1597967570 | K150022 | Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream | LCX | 2015-08-07 |
| 188083 | 1617106572 | K041408 | POLYMEDCO OC AUTO MICRO 80 FOB TEST | OOX | 2004-10-21 |
| 188083 | 1709560234 | K012043 | VACUETTE EDTA K2 GEL TUBES | PJE | 2001-09-24 |
| 188083 | 2029420613 | BK050036 | |||
| 195214 | 1475681398 | ||||
| 188083 | 1163526318 | ||||
| 188083 | 1237111895 | ||||
| 188083 | 1259057341 | ||||
| 188083 | 1344597776 | ||||
| 188083 | 1381089618 | ||||
| 188083 | 1461683743 | ||||
| 188083 | 1475681398 | ||||
| 188083 | 1515930632 | ||||
| 188083 | 1527657302 | ||||
| 188083 | 1532835822 | ||||
| 188083 | 1538589066 | ||||
| 188083 | 1610327039 | ||||
| 188083 | 1618709855 | ||||
| 188083 | 1640463620 | ||||
| 188083 | 1642176503 | ||||
| 188083 | 1694446326 | ||||
| 188083 | 1698685054 | ||||
| 188083 | 1729864250 | ||||
| 188083 | 1747974386 | ||||
| 188083 | 1781359815 | ||||
| 188083 | 1822855966 | ||||
| 188083 | 1897576857 | ||||
| 188083 | 1910397139 | ||||
| 188083 | 1965156371 | ||||
| 188083 | 1998797412 | ||||
| 188083 | 2013173826 | ||||
| 188083 | 2026662352 | ||||
| 188083 | 2034581929 | ||||
| 188083 | 2044679618 |
Product Codes Associated With Registrations#
GUDID#
Aero-Med - PF Plus Bottle Kit for Simple Laboratories
2026-09-25
Aero-Med - GI PATHOGEN TESTING KIT
2026-09-24
CARDINAL HEALTH - SPECIMEN KIT, BONE MARROW, PATH CON
2019-04-12
Aero-Med - Bone Marrow Biopsy Kit, CompuNet Clinical Laboratories Only
2021-02-24
Aero-Med - Prostate Biopsy Kit for Cottage Health - PDL only
2026-02-20
Aero-Med - Prostate Collection Kit for Champlain Valley Physician Hospital Medical Center
2026-02-20
Aero-Med - Kit Prostate Biopsy for CentraCare Health System Only
2023-02-24
Aero-Med - Kit Prostate Biopsy for North Mississippi Medical Center Only
2023-04-20
Aero-Med - Kit Prostate Biopsy Transport Kit for Contra Costa Pathology Labs Only
2024-05-10
Aero-Med - Kit Bone Marrow Biopsy for Sagis Diagnostics Only
2024-08-28
Aero-Med - Kit Specimen Collection - Biopsy/Tissue/Organ - for Sentara Only
2025-06-19
Aero-Med - SurePath Cytology Convenience Kit, Health Partners Only
2026-02-13
Aero-Med - Neuropath Specimen Kit, Transport, Stanford Medical Center Only
2026-03-20
Aero-Med - Bone Marrow Lab Kit, St. Luke's University Health Network, Bethlehem PA Only
2019-10-07
Aero-Med - Kit Urine Collection for Behavioral Health for UNC Health Only
2024-01-31
Aero-Med - 23G Pediatric Blood Culture for St. Barnabas Healthcare Only
2026-06-10
Aero-Med - Kit ABG Blood Collection for Ohio Health Only
2026-06-10
Aero-Med - Blood Culture Collection Kit, PIV Steripath, Trial Only Revision
2022-08-26
Aero-Med - Kit Arterial Blood Collection for Shannon Medical Center Only
2022-08-26
Aero-Med - Kit Pediatric Arterial Blood Collection for Shannon Medical Center Only
2022-08-26
Aero-Med - Kit Blood Culture Adult 21G for Rangely Hospital District Only
2023-02-14
Aero-Med - Kit Blood Culture Pediatric 23G for Rangely Hospital District Only
2023-02-14
Aero-Med - Kit ABG Blood Collection for Ashtabula County Medical Center Only
2023-03-15
Aero-Med - Kit Blood Culture Line Draw for Cleveland Clinic Only
2023-10-12
Aero-Med - Kit Blood Culture - venipuncture, Sentara only
2022-07-20
Aero-Med - Kit Blood Culture - Line Draw for Sentara only
2022-07-20
Aero-Med - Kit Urine Collection for Pharma GenLabs Only
2022-08-10
Aero-Med - Kit Blood Collection for MedScan Labs Only
2022-08-24
Aero-Med - Kit Urine Collection CarolinaEast
2022-09-09
Aero-Med - Kit Blood Culture Adult for Adventist Health - Tulare Only
2022-10-04
Aero-Med - Kit Blood Culture Adult for Adventist Health - CVN Only
2022-10-04
Aero-Med - Kit Adult Blood Culture for Adventist Health Bakersfield Only
2022-10-14
Aero-Med - Kit Blood Culture - Magnolia 10cc Syringe BMX
2022-11-21
Aero-Med - Kit Bone Marrow Collection for BILH Plymouth Only
2022-12-15
Aero-Med - Kit Blood Culture Adult for USC Verdugo Hills Hospital Only
2023-01-10
Aero-Med - Kit Urine Collection for Beebe Medical Center Only
2023-03-09
Aero-Med - Kit Blood Culture for Shirley Ryan Rehabilitation Institute
2023-03-21
Aero-Med - Kit Blood Culture for Health & Hospitals NYC Only
2023-04-26
Aero-Med - Pediatric Blood Culture Kit, Sentara Only
2023-06-14