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) (8) Aspiration tray (OJT) (2)

Premarket Exempt

No Yes

Clear

Aero-Med - 00810010892096 Catalog Number : AMM2225

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 - 00810010892102 Catalog Number : LCA210

Device Description : Thyroid FNA Kit w/ RNA Retain

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OJT

Prescription Use : No

Device Count : 1

Aero-Med - 00810010892119 Catalog Number : FNAK10

Device Description : Fine Needle Aspiration Kit

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OJT

Prescription Use : No

Device Count : 1

Aero-Med - 00810010892126 Catalog Number : LCA350

Device Description : Adult Blood Cutlure Kit

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

Aero-Med - 00810010892133 Catalog Number : LCA360

Device Description : Pediatric Blood Culture Kit

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

Aero-Med - 00810010892140 Catalog Number : LCA355

Device Description : Blood Culture Collection Kit - Adult

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

Aero-Med - 00810010892157 Catalog Number : LCA365

Device Description : Blood Culture Collection Kit - Pediatric

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

Aero-Med - 00810010892164 Catalog Number : LCA184

Device Description : Single Test Pack, Quantiferon TB

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

Aero-Med - 00810010892171 Catalog Number : LCA188

Device Description : Single Test Pack, HA Quantiferon TB

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

CARDINAL HEALTH - 00810010892188 Catalog Number : AMM1958

Device Description : BLOOD COLLECTION SET, VITAMIN D

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

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