Aero-Med, Ltd.

Address:65 Olde Roberts St,East Hartford,CT,06108,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Blood and urine collection kit (excludes HIV testing) (OIB) (6) TRAY, SURGICAL (LRP) (4)

Premarket Exempt

No Yes

Clear

Aero-Med - 00810010892317 Catalog Number : 00WOUNDKIT04

Device Description : Hydrogel Bridge Kit

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : No

Device Count : 1

Aero-Med - 00810010892324 Catalog Number : QUE2150

Device Description : Sweat Collection Kit

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : No

Device Count : 1

Aero-Med - 00810010892331 Catalog Number : AMM2275

Device Description : Two Card - Dried Blood Spot kit

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

Aero-Med - 00810010892348 Catalog Number : AMM2300

Device Description : Single Card - Dried Blood Spot kit

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

Aero-Med - 00810010892355 Catalog Number : AMM2325

Device Description : Re-Collect - Single Card - Dried Blood Spot kit

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

Aero-Med - 00810010892362 Catalog Number : AMM2350

Device Description : Re-Collect - Two Card - Dried Blood Spot kit

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

Aero-Med - 00810010892379 Catalog Number : AMM2375

Device Description : Amazon Direct - Two Card - Dried Blood Spot Kit

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

Aero-Med - 00810010892386 Catalog Number : BHD1900

Device Description : Blood Collection Kit

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

Aero-Med - 00810010892393 Catalog Number : CMT01-FL

Device Description : Serum Separator Card

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : No

Device Count : 1

Aero-Med - 00810010892409 Catalog Number : BHD400A

Device Description : Buccal Swab Kit

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : No

Device Count : 1

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