PEPPER MEDICAL INC.

Address:600 W Strasburg Rd,West Chester,PA,19382,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

CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE) (BYD) (8) DEVICE, FIXATION, TRACHEAL TUBE (CBH) (1) Filter, bacterial, breathing-circuit (CAH) (1)

Premarket Exempt

No Yes

Clear

Trach Tie - 00850014574413 Catalog Number : 502P

Device Description : Pedi Trach Tube Holder

Device Class : 1

Duns Number: 622637098

Premarket Exempt : Yes

Product Code : CBH

Prescription Use : No

Device Count : 10

HME - 00850014574420 Catalog Number : HME-01P

Device Description : Heat Moisture Exchanger with Paper

Device Class :

Duns Number: 622637098

Premarket Exempt : Yes

Product Code : BYD

Prescription Use : No

Device Count : 1

HME - 00850014574437 Catalog Number : HME-02P

Device Description : Heat Moisture Exchanger with Paper and 02 Port

Device Class :

Duns Number: 622637098

Premarket Exempt : Yes

Product Code : BYD

Prescription Use : No

Device Count : 1

HME - 00850014574444 Catalog Number : HME-01F

Device Description : Heat Moisture Exchanger with Foam

Device Class :

Duns Number: 622637098

Premarket Exempt : Yes

Product Code : BYD

Prescription Use : No

Device Count : 1

HME - 00850014574451 Catalog Number : HME-02F

Device Description : Heat Moisture Exchanger with Foam and 02 Port

Device Class : 1

Duns Number: 622637098

Premarket Exempt : Yes

Product Code : BYD

Prescription Use : No

Device Count : 50

HME - 00850014574468 Catalog Number : HME-02-Sux

Device Description : Heat Moisture Exchanger with Paper and 02 Port / Suction Port

Device Class : 1

Duns Number: 622637098

Premarket Exempt : Yes

Product Code : BYD

Prescription Use : No

Device Count : 50

HME - 00850014574475 Catalog Number : HME001

Device Description : Heat Moisture Exchanger with Paper

Device Class : 1

Duns Number: 622637098

Premarket Exempt : Yes

Product Code : BYD

Prescription Use : No

Device Count : 50

HME - 00850014574482 Catalog Number : HME-Mini-P

Device Description : Heat Moisture Exchanger with Paper

Device Class :

Duns Number: 622637098

Premarket Exempt : Yes

Product Code : BYD

Prescription Use : No

Device Count : 1

HME - 00850014574499 Catalog Number : HMEF711C

Device Description : Heat Moisture Exchanger with Filter

Device Class :

Duns Number: 622637098

Premarket Exempt : No

Product Code : CAH

Prescription Use : No

Device Count : 1

HME - 00850014574505 Catalog Number : HME-03P

Device Description : Heat Moisture Exchanger with Paper and 02 Port / Suction Port

Device Class :

Duns Number: 622637098

Premarket Exempt : Yes

Product Code : BYD

Prescription Use : No

Device Count : 1

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