B.L.S. Systems Limited

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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) (6) Mask, Gas, Anesthetic (BSJ) (4)

Premarket Exempt

No Yes

Clear

Rescuer Disposable Resuscitation Cushion Mask (#3 Child) - B0021510 Catalog Number : 1510

Device Description : Rescuer Disposable Resuscitation Cushion Mask (#3 Child)

Device Class : 1

Duns Number: 200103823

Premarket Exempt : Yes

Product Code : BSJ

Prescription Use : Yes

Device Count : 1

Rescuer Disposable Resuscitation Cushion Mask (#2 Infant) - B00215150 Catalog Number : 1515

Device Description : Rescuer Disposable Resuscitation Cushion Mask (#2 Infant)

Device Class : 1

Duns Number: 200103823

Premarket Exempt : Yes

Product Code : BSJ

Prescription Use : Yes

Device Count : 1

Rescuer Disposable Resuscitation Cushion Mask (#1 Infant) - B00215200 Catalog Number : 1520

Device Description : Rescuer Disposable Resuscitation Cushion Mask (#1 Infant)

Device Class : 1

Duns Number: 200103823

Premarket Exempt : Yes

Product Code : BSJ

Prescription Use : Yes

Device Count : 1

Rescuer Disposable Resuscitation Cushion Mask (#0 Neonate) - B00215250 Catalog Number : 1525

Device Description : Rescuer Disposable Resuscitation Cushion Mask (#0 Neonate)

Device Class : 1

Duns Number: 200103823

Premarket Exempt : Yes

Product Code : BSJ

Prescription Use : Yes

Device Count : 1

Facemask with one way valve - B00220000 Catalog Number : 2000

Device Description : Rescuer Disposable CPR face mask with one way valve.

Device Class : 2

Duns Number: 200103823

Premarket Exempt : No

Product Code : CBP

Prescription Use : Yes

Device Count : 1

Rescuer CPR Mask in Hard Shell Carrying Case - B0022000CC0 Catalog Number : 2000CC

Device Description : Rescuer CPR Mask with one way valve in Hard Shell Carrying Case

Device Class :

Duns Number: 200103823

Premarket Exempt : No

Product Code : CBP

Prescription Use : Yes

Device Count : 1

Facemask with O2, headstrap and one way valve - B0022025HS0 Catalog Number : 2025-HS

Device Description : Rescuer disposable CPR mask with oxygen inlet, head strap and one way valve

Device Class : 2

Duns Number: 200103823

Premarket Exempt : No

Product Code : CBP

Prescription Use : Yes

Device Count : 1

Rescuer CPR Facemask with O2, head strap, One way Valve in Hard Shell Case - B0022025HSCC0 Catalog Number : 2025-HS-CC

Device Description : Rescuer disposable CPR facemask with oxygen inlet, head strap, one way valve in Rescuer disposable CPR facemask with oxygen inlet, head strap, one way valve in a hard shell case

Device Class :

Duns Number: 200103823

Premarket Exempt : No

Product Code : CBP

Prescription Use : Yes

Device Count : 1

Rescuer 2025-HS-CC with Nitrile gloves - B0022025HSCCX0 Catalog Number : 2025-HS-CCX

Device Description : Rescuer disposable CPR mask with oxygen inlet, head strap, one way valve, hard s Rescuer disposable CPR mask with oxygen inlet, head strap, one way valve, hard shell case and 2 nitrile gloves

Device Class :

Duns Number: 200103823

Premarket Exempt : No

Product Code : CBP

Prescription Use : Yes

Device Count : 1

Faceshield with one way valve - B00220300 Catalog Number : 2030

Device Description : CPR faceshield with one way valve

Device Class :

Duns Number: 200103823

Premarket Exempt : No

Product Code : CBP

Prescription Use : Yes

Device Count : 1

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