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) (7) TRAY, SURGICAL (LRP) (3)

Premarket Exempt

No Yes

Clear

Aero-Med - 00810010892591 Catalog Number : BHD1900A

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 - 00810010892652 Catalog Number : AMM2500

Device Description : Comprehensive GE Single Card Complete Boxed Dried Blood Spot Kit

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

Aero-Med - 00810010892669 Catalog Number : AMM2525

Device Description : Comprehensive GESingle Card Replacement Kit

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

Aero-Med - 00810010892676 Catalog Number : AMM2575

Device Description : AMH GE Single Card Complete Boxed Dried Blood Spot Kit

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

Aero-Med - 00810010892683 Catalog Number : AMM2600

Device Description : AMH GE Single Card Replacement Kit

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

Aero-Med - 00810010892706 Catalog Number : BHD1900B

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 - 00810010892737 Catalog Number : AMM3675

Device Description : Patient Supply Box

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : No

Device Count : 1

Aero-Med - 00810010892744 Catalog Number : LCA2025

Device Description : COVID-19 Test Kit

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : No

Device Count : 1

Aero-Med - 00810010892751 Catalog Number : AMM518

Device Description : Urine Foley Catheter Kit

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

Aero-Med - 00810010892768 Catalog Number : AMM3675A

Device Description : Patient supply Box

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : No

Device Count : 1

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