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) (10)

Premarket Exempt

No Yes

Clear

Aero-Med - 10885380193484 Catalog Number : CA44575

Device Description : Kit Blood Culture Adult for Adventist Health CVN Only

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

Aero-Med - 10885380193507 Catalog Number : CA43525

Device Description : Kit Urine Foley Collection for Health First Only

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

Aero-Med - 10885380193514 Catalog Number : CA37125

Device Description : Kit Arterial Blood Collection for Shannon Medical Center Only

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

Aero-Med - 10885380193521 Catalog Number : CA37875

Device Description : Kit Pediatric Arterial Blood Collection for Shannon Medical Center Only

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

Aero-Med - 10885380193538 Catalog Number : CA44225

Device Description : Kit Urine Collection for Pharma GenLabs Only

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

Aero-Med - 10885380193545 Catalog Number : CA44600

Device Description : Kit Arterial Blood Collection for Raleigh General Only

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

Aero-Med - 10885380193637 Catalog Number : CA44875

Device Description : Kit Blood Collection for MedScan Labs Only

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

Aero-Med - 10885380193675 Catalog Number : CA43775

Device Description : Kit Urine Collection CarolinaEast

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

Aero-Med - 10885380193743 Catalog Number : CA44700

Device Description : Kit Blood Culture 21G Magnolia for Piedmont Athens Only

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

Aero-Med - 10885380193750 Catalog Number : CA44750

Device Description : Kit Blood Culture - Line Draw Magnolia for Piedmont Athens Only

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

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