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) (7) CONTAINER, SPECIMEN MAILER AND STORAGE, NON-STERILE (NNK) (2) Kit, surgical instrument, disposable (KDD) (1)

Premarket Exempt

No Yes

Clear

Aero-Med - 10885380184390 Catalog Number : CA14850A

Device Description : Blood Collection Kit, Donor, Duke Medical Center Only

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

Aero-Med - 10885380184406 Catalog Number : CA36800

Device Description : Specimen Transport and Shipper, Medium, Common Spirit Health Only

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : NNK

Prescription Use : No

Device Count : 1

Aero-Med - 10885380184413 Catalog Number : CA36825

Device Description : Specimen Transport and Shipper, Large, Common Spirit Health Only

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : NNK

Prescription Use : No

Device Count : 1

Aero-Med - 10885380184642 Catalog Number : CA13000B

Device Description : Pediatric CIV Kit for University of Kansas Health System

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

Aero-Med - 10885380186363 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 - 10885380189364 Catalog Number : CA40975

Device Description : CA40975 Skin Punch Biopsy Kit for Arkana Lab Only

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : KDD

Prescription Use : No

Device Count : 1

Aero-Med - 10885380193255 Catalog Number : CA2250C

Device Description : Kit Blood Culture - venipuncture, Sentara only

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

Aero-Med - 10885380193262 Catalog Number : CA2275B

Device Description : Kit Blood Culture - Line Draw for Sentara only

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

Aero-Med - 10885380193415 Catalog Number : CA28600A

Device Description : Blood Culture Collection Kit, PIV Steripath, Trial Only Revision

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

Aero-Med - 10885380193477 Catalog Number : CA44550

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

Device Class : 1

Duns Number: 194550042

Premarket Exempt : Yes

Product Code : OIB

Prescription Use : No

Device Count : 1

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