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) (10)

Premarket Exempt

No Yes

Clear

Aero-Med - 10885380183409 Catalog Number : CA34900

Device Description : Blood Culture Collection Kit, Peripheral Draw, Cedars Sinai Medical Center Only

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

Aero-Med - 10885380183591 Catalog Number : CA22825A

Device Description : Blood Culture Collection Kit, Brookwood Baptist Only

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

Aero-Med - 10885380183607 Catalog Number : CA34475A

Device Description : Viral Collection and Transport Kit, OP Swab, Bulk, Essentia Health Only

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

Aero-Med - 10885380183652 Catalog Number : CA34700

Device Description : COVID-19 Collection Kit, Kaiser Permanente HI Only

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

Aero-Med - 10885380183935 Catalog Number : CA36275

Device Description : Viral Collection Kit, OP Swab, Saline, Cooper University Hospital Only

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

Aero-Med - 10885380183980 Catalog Number : CA35050

Device Description : Viral Collection Transport Kit, SLC Health System Only

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

Aero-Med - 10885380183997 Catalog Number : CA36225

Device Description : Viral Collection and Transport Kit, NP Swab, St. Clair Hospital Only

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

Aero-Med - 10885380184000 Catalog Number : CA36250

Device Description : Viral Collection and Transport Kit, OP Swab, St. Clair Hospital Only

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

Aero-Med - 10885380184024 Catalog Number : CA36450

Device Description : Viral Collection Kit, NP, Hoag Memorial Hospital Only

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

Aero-Med - 10885380184031 Catalog Number : CA36350

Device Description : COVID-19 Collection Kit Kingman Reg

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

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