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) (9) TRAY, SURGICAL (LRP) (1)

Premarket Exempt

No Yes

Clear

Aero-Med - 10885380184062 Catalog Number : CA36525

Device Description : Blood Culture Collection Kit, Includes Discard Tube, Calvert Health Medical Center Only

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

Aero-Med - 10885380184079 Catalog Number : CA35825

Device Description : Viral Collection Kit, St Alphonsus Regional Medical Center Only

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

Aero-Med - 10885380184161 Catalog Number : CA35400

Device Description : Viral Transport Kit, National Jewish Health Advanced Diagnostic Laboratories Only

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

Aero-Med - 10885380184208 Catalog Number : CA40000

Device Description : Viral Transport Kit, Nasopharyngeal Swab, 3mL VTM

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

Aero-Med - 10885380184215 Catalog Number : CA50000

Device Description : Viral Transport Kit, Oropharyngeal Swab, 3mL VTM

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

Aero-Med - 10885380184260 Catalog Number : CA31850

Device Description : Blood Culture Kit, SteriPath Gen2, 21G, Stillwater Medical Center Only

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

Aero-Med - 10885380184321 Catalog Number : CA36200

Device Description : Blood Culture Collection Kit, PIV SteriPath Gen2, Stillwater Medical Center Only

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

Aero-Med - 10885380184352 Catalog Number : CA34925

Device Description : Blood Culture Collection Kit, Luer IV Steripath Gen2, Baylor Scott & White Only

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

Aero-Med - 10885380184369 Catalog Number : CA34950

Device Description : Blood Culture Collection Kit, 23G SteriPath Gen2, Baylor Scott & White Only

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

Aero-Med - 10885380184376 Catalog Number : CA3100A

Device Description : Bone Marrow Biopsy Kit, CompuNet Clinical Laboratories Only

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : No

Device Count : 1

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