BMC Medical Co., Ltd.

Address:Room 901, Building 1,Beijing,CN

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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 Yes

Clear

NA - 06948538360590 Catalog Number :

Device Description : Siesta Nasal Mask

Device Class : 2

Duns Number: 526010310

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

NA - 06948538360606 Catalog Number :

Device Description : Siesta Full Face Mask

Device Class : 2

Duns Number: 526010310

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

NA - 06948538360613 Catalog Number :

Device Description : Siesta Full Face Mask

Device Class : 2

Duns Number: 526010310

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

NA - 06948538360620 Catalog Number :

Device Description : Siesta Full Face Mask

Device Class : 2

Duns Number: 526010310

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

/ - 06948538360712 Catalog Number :

Device Description : Siesta Full Face Mask (SML)

Device Class : 2

Duns Number: 526010310

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

InH2® - 06948538362013 Catalog Number :

Device Description : RESmart® Integrated Heated Humidifier for CPAP

Device Class : 2

Duns Number: 526010310

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

InH2® - 06948538362020 Catalog Number :

Device Description : RESmart® Integrated Heated Humidifier for Auto CPAP

Device Class : 2

Duns Number: 526010310

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

InH2® - 06948538362037 Catalog Number :

Device Description : RESmart® Integrated Heated Humidifierfor BPAP 25A

Device Class : 2

Duns Number: 526010310

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Luna® - 06948538362044 Catalog Number :

Device Description : Luna® Integrated Heated Humidifier

Device Class : 2

Duns Number: 526010310

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

iCodeConnect® - 06948538362075 Catalog Number :

Device Description : iCodeConnect Software

Device Class : 2

Duns Number: 526010310

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

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