Innomed Technologies Inc

Innomed Technologies 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

Ventilator, Non-Continuous (Respirator) (BZD) (10)

Premarket Exempt

No

Clear

Hybrid - 00833224000156 Catalog Number : HYB500

Device Description : Hybrid Face Mask - All Sizes Kit

Device Class :

Duns Number: 103307950

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Hybrid - 00833224000163 Catalog Number : HYB515

Device Description : Hybrid Cushion- LG

Device Class :

Duns Number: 103307950

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

Hybrid - 00833224000170 Catalog Number : HYB513

Device Description : Hybrid Cushion- MD

Device Class :

Duns Number: 103307950

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

Hybrid - 00833224000187 Catalog Number : HYB511

Device Description : Hybrid Cushion- SM

Device Class :

Duns Number: 103307950

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

Hybrid - 00833224000194 Catalog Number : HYB525

Device Description : Hybrid Pillows - LG

Device Class :

Duns Number: 103307950

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

Hybrid - 00833224000200 Catalog Number : HYB523

Device Description : Hybrid Pillows - MD

Device Class :

Duns Number: 103307950

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

Hybrid - 00833224000217 Catalog Number : HYB521

Device Description : Hybrid Pillows - SM

Device Class :

Duns Number: 103307950

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

Hybrid - 00833224000231 Catalog Number : HYB540

Device Description : Hybrid SLV Face Mask – All Sizes Kit

Device Class : 2

Duns Number: 103307950

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Hybrid AV - 00833224000248 Catalog Number : HYB555

Device Description : Hybrid AV Face Mask – LG

Device Class :

Duns Number: 103307950

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Hybrid AV - 00833224000255 Catalog Number : HYB553

Device Description : Hybrid AV Face Mask – MD

Device Class : 2

Duns Number: 103307950

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

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