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

TRAY, SURGICAL (LRP) (6) Blood and urine collection kit (excludes HIV testing) (OIB) (4)

Premarket Exempt

No Yes

Clear

CARDINAL HEALTH - 00810010892195 Catalog Number : AMM1959

Device Description : BLOOD COLLECTION SET, WOMENS WELLNESS

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

CARDINAL HEALTH - 00810010892201 Catalog Number : AMM1675

Device Description : NEEDLE/HOLDER CONVENIENCE KIT

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : No

Device Count : 1

Aero-Med - 00810010892218 Catalog Number : AMM930

Device Description : KIT, URINE TRANSFER STRAW

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

Aero-Med - 00810010892225 Catalog Number : AMM400

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 - 00810010892232 Catalog Number : 00WOUNDKIT01

Device Description : Dry-Bridge Kit

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : No

Device Count : 1

Aero-Med - 00810010892249 Catalog Number : 00WOUNDKIT02

Device Description : Heavy-Bridge Kit

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : No

Device Count : 1

Aero-Med - 00810010892256 Catalog Number : 00WOUNDKIT03

Device Description : Hydrogel-Bridge Kit

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : No

Device Count : 1

CARDINAL HEALTH - 00810010892263 Catalog Number : LCA290

Device Description : Kidney Stone Transportation Box Kit

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : No

Device Count : 1

Aero-Med - 00810010892270 Catalog Number : AMM997

Device Description : Urine Transfer Straw

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

CARDINAL HEALTH - 00810010892300 Catalog Number : AMM1960FIT

Device Description : AT HOME STOOL COLLECTION KIT

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : No

Device Count : 1

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