Aero-Med, Ltd.

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

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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) (4) TRAY, SURGICAL (LRP) (3) CONTAINER, SPECIMEN MAILER AND STORAGE, NON-STERILE (NNK) (1) Tape and bandage, adhesive (KGX) (1) Tubes, vials, systems, serum separators, blood collection (JKA) (1)

Premarket Exempt

Yes No

Clear

Aero-Med - 00810010892775 Catalog Number : BHD3400

Device Description : Covid-19 Collection Kit

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

Aero-Med - 00810010892782 Catalog Number : BHD3500

Device Description : Covid-19 Collection Kit ( Convienience Packaging)

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

Aero-Med - 00810010892799 Catalog Number : BHD3600

Device Description : Covid-19 Collection Kit ( Convienience Packaging)

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

Aero-Med - 00810010892805 Catalog Number : LCA850

Device Description : Family DNA KIT

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : NNK

Prescription Use : No

Device Count : 1

Aero-Med - 00810010892812 Catalog Number : QUE2275

Device Description : Employer Solution Hair Kits- Convenience Package

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : No

Device Count : 1

Aero-Med - 00810010892829 Catalog Number : BHD3700

Device Description : Convenience Packaging Kit

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : No

Device Count : 1

Aero-Med - 00810010892836 Catalog Number : BHD3800

Device Description : Convenience Packaging Kit

Device Class : 2

Duns Number: 194550042

Premarket Exempt : No

Product Code : JKA

Prescription Use : No

Device Count : 1

Aero-Med - 00810010892850 Catalog Number : LCA2125

Device Description : Covid Antibody Test Kit

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

Aero-Med - 00810010892911 Catalog Number : AM100-PL

Device Description : Bandage Plastic 3/4X3IN STR LF

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

Aero-Med - 00810010892973 Catalog Number : AMM3675B

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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