Spiracle Technology

Spiracle Technology

Address:10601 Calle Lee Ste 190,Los Alamitos,CA,90720,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

Valve, Non-Rebreathing (CBP) (3) Ventilator, Emergency, Manual (Resuscitator) (BTM) (3) Catheters, Suction, Tracheobronchial (BSY) (2) Mask, Oxygen, Non-Rebreathing (KGB) (2) Blood Pressure Cuff (DXQ) (1)

Premarket Exempt

No Yes

Clear

FERNO2 - 00814940020048 Catalog Number :

Device Description : MVP Manual Aspirator

Device Class : 1

Duns Number: 836002451

Premarket Exempt : Yes

Product Code : BSY

Prescription Use : No

Device Count : 1

FERNO2 - 00814940020055 Catalog Number :

Device Description : BVM, Adult, Single Patient Use

Device Class : 2

Duns Number: 836002451

Premarket Exempt : No

Product Code : BTM

Prescription Use : No

Device Count : 1

FERNO2 - 00814940020062 Catalog Number :

Device Description : BVM, Child, Single Patient Use

Device Class : 2

Duns Number: 836002451

Premarket Exempt : No

Product Code : BTM

Prescription Use : No

Device Count : 1

FERNO2 - 00814940020079 Catalog Number :

Device Description : BVM, Infant, Single Patient Use

Device Class : 2

Duns Number: 836002451

Premarket Exempt : No

Product Code : BTM

Prescription Use : No

Device Count : 1

FERNO2 - 00814940020093 Catalog Number :

Device Description : CPR Mask

Device Class : 1

Duns Number: 836002451

Premarket Exempt : No

Product Code : KGB, CBP

Prescription Use : No

Device Count : 1

FERNO2 - 00814940020109 Catalog Number :

Device Description : Wall-Mounted Blood Pressure Cuff

Device Class : 2

Duns Number: 836002451

Premarket Exempt : No

Product Code : DXQ

Prescription Use : No

Device Count : 1

FERNO2 HFOC - 00814940020185 Catalog Number : T25301

Device Description : HFOC valve, refill valve for use with Bag Valve Mask resuscitator.

Device Class : 2

Duns Number: 836002451

Premarket Exempt : No

Product Code : CBP

Prescription Use : No

Device Count : 1

FERNO2 OX Inhalator - 00814940020208 Catalog Number : T25302-10

Device Description : OX Series Inhalator valve, demand valve used with spontaneously breathing patients

Device Class : 2

Duns Number: 836002451

Premarket Exempt : No

Product Code : CBP

Prescription Use : No

Device Count : 1

FERNO2 - 00814940020505 Catalog Number :

Device Description : Collection Bottle With Large Bore Catheter

Device Class : 1

Duns Number: 836002451

Premarket Exempt : Yes

Product Code : BSY

Prescription Use : No

Device Count : 1

FERNO2 - 00814940020833 Catalog Number :

Device Description : Silicone Cuffed Mask: Size 0

Device Class : 1

Duns Number: 836002451

Premarket Exempt : No

Product Code : KGB

Prescription Use : No

Device Count : 1

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