NSPIRE HEALTH, INC.

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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

Filter, Bacterial, Breathing-Circuit (CAH) (10) Clip, Nose (BXJ) (4) Mouthpiece, Breathing (BYP) (4)

Premarket Exempt

No Yes

Clear

nSpire Health - 10852417003603 Catalog Number : 810000

Device Description : KoKo Standard Pulmonary Function Filter, Blue for KoKo Sx, KoKo Legend, KoKo Dig

Device Class :

Duns Number: 184817096

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 100

nSpire Health - 10852417003610 Catalog Number : 810005

Device Description : KoKo Standard Blue Filter kit with Foam Nose Clips for use with KoKo, KoKo SX, L

Device Class :

Duns Number: 184817096

Premarket Exempt : No

Product Code : BXJ, CAH

Prescription Use : Yes

Device Count : 100

nSpire Health - 10852417003627 Catalog Number : 810580

Device Description : KoKo Standard Blue Filter Kit with Nose Clip and Rubber Mouthpiece for use with

Device Class :

Duns Number: 184817096

Premarket Exempt : No

Product Code : CAH, BYP, BXJ

Prescription Use : Yes

Device Count : 50

nSpire Health - 10852417003634 Catalog Number : 811000

Device Description : KoKo Standard Pulmonary Function Filter, White for KoKo Sx, KoKo Legend, KoKo Di

Device Class :

Duns Number: 184817096

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 100

nSpire Health - 10852417003641 Catalog Number : 815000

Device Description : KoKo Standard Pulmonary Function Filter, White, Green, Blue, and Yellow for KoKo

Device Class :

Duns Number: 184817096

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 100

nSpire Health - 10852417003665 Catalog Number : 891580

Device Description : KoKo Standard White Filter Kit with Nose Clip and Rubber Mouthpiece for use with

Device Class :

Duns Number: 184817096

Premarket Exempt : No

Product Code : CAH, BYP, BXJ

Prescription Use : Yes

Device Count : 50

nSpire Health - 10852417003672 Catalog Number : K022454

Device Description : KoKo Standard Pulmonary Function Filter, White for KoKo Px, HDpft, Collins. Box of 100.

Device Class :

Duns Number: 184817096

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 100

nSpire Health - 10852417003689 Catalog Number : K022462

Device Description : KoKo Pulmonary Function Filter Kit, White with Rubber Mouthpiece for KoKo Px, HD

Device Class :

Duns Number: 184817096

Premarket Exempt : No

Product Code : BYP, CAH

Prescription Use : Yes

Device Count : 100

nSpire Health - 10852417003696 Catalog Number : K022465

Device Description : KoKo Standard White Filter Kit with Nose Clip and Rubber Mouthpiece for use with

Device Class :

Duns Number: 184817096

Premarket Exempt : No

Product Code : BXJ, BYP, CAH

Prescription Use : Yes

Device Count : 100

nSpire Health - 10852417003702 Catalog Number : 831000

Device Description : KoKo Standard Pulmonary Function Filter, White, 30mm ID x 34mm OD for most Senso

Device Class :

Duns Number: 184817096

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 100

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