3B MEDICAL, INC.

Address:203 Avenue A NW,Winter Haven,FL,33881,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

Ventilator, Non-Continuous (Respirator) (BZD) (8) Generator, Oxygen, Portable (CAW) (1) Nebulizer (Direct Patient Interface) (CAF) (1)

Premarket Exempt

No Yes

Clear

3B Medical, Inc. Qube Compressor Nebulizer - 00817783020251 Catalog Number :

Device Description : Nebulisers are devices used to deliver atomised particles of drug to the airways Nebulisers are devices used to deliver atomised particles of drug to the airways via compressed air

Device Class : 2

Duns Number: 078517316

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

3B Medical Aer - 00853041003000 Catalog Number : 021000M

Device Description : Aer X is a portable Oxygen concentrator

Device Class : 2

Duns Number: 078517316

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

3B Medical, Inc. - 00853041003048 Catalog Number :

Device Description : replacement headgear for 3B Medical's ECCO full face mask, this headgear is not replacement headgear for 3B Medical's ECCO full face mask, this headgear is not size specific

Device Class : 2

Duns Number: 078517316

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

3B medical, inc. - 00853041003079 Catalog Number :

Device Description : 3B Medical, Inc. Rio Nasal Pillow system replacement cushion size SMALL

Device Class : 2

Duns Number: 078517316

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

3B Medical, Inc. - 00853041003086 Catalog Number :

Device Description : 3B Medical, Inc. Rio Nasal Pillow system replacement cushion size MEDIUM

Device Class : 2

Duns Number: 078517316

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

3B Medical, Inc. - 00853041003093 Catalog Number :

Device Description : 3B Medical, Inc. Rio Nasal Pillow system replacement cushion size LARGE

Device Class : 2

Duns Number: 078517316

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

3B Medical, Inc. - 00853041003222 Catalog Number :

Device Description : 3B Medical, Inc's Rio Nasal Pillow Mask All Size Kit includes the nasal mask, he 3B Medical, Inc's Rio Nasal Pillow Mask All Size Kit includes the nasal mask, headgear and nasal pillow cushions in small, medium and largeThis mask is for use with a CPAP or bi-level machine.

Device Class : 2

Duns Number: 078517316

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

3B Medical, Inc - 00853041003239 Catalog Number :

Device Description : 3B Medical Inc.'s Replacement Frame + Nasal Pillow replacement for the Rio Nasa 3B Medical Inc.'s Replacement Frame + Nasal Pillow replacement for the Rio Nasal Pillow System size SMALL

Device Class : 2

Duns Number: 078517316

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

3B Medical, Inc. - 00853041003246 Catalog Number :

Device Class : 2

Duns Number: 078517316

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

3B Medical, Inc. - 00853041003253 Catalog Number :

Device Description : 3B Medical, Inc Rio Nasal Pillow mask Smallincludes a mask, headgear and a small 3B Medical, Inc Rio Nasal Pillow mask Smallincludes a mask, headgear and a small nasal pillow cushion

Device Class : 2

Duns Number: 078517316

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

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