B.L.S. Systems Limited

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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, Emergency, Manual (Resuscitator) (BTM) (8) Attachment, Breathing, Positive End Expiratory Pressure (BYE) (2)

Premarket Exempt

No Yes

Clear

Rescuer - B0024000F0 Catalog Number : 4000F

Device Description : HEPA Filter component for Rescuer BVM Manual Resuscitator (Emergency Manual Ventilator)

Device Class :

Duns Number: 200103823

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

Disposable PEEP Valve - B0024000PEEP0 Catalog Number : 4000-PEEP

Device Description : Disposable PEEP valve for use on the Rescuer manual resuscitator.

Device Class :

Duns Number: 200103823

Premarket Exempt : No

Product Code : BYE

Prescription Use : Yes

Device Count : 1

Disposable PEEP valve with converter - B0024000PVC0 Catalog Number : 4000-PVC

Device Description : Disposable PEEP valve with converter to be used with manual resuscitators.

Device Class :

Duns Number: 200103823

Premarket Exempt : No

Product Code : BYE

Prescription Use : Yes

Device Count : 1

Rescuer BVM Manual Resuscitator with Universal Tubing - B0024000U0 Catalog Number : 4000U

Device Description : Rescuer Adult disposable manual resuscitator with 2900 Ml reservoir, #5 cushion Rescuer Adult disposable manual resuscitator with 2900 Ml reservoir, #5 cushion mask and 2 m crush proof oxygen tubing with universal style connector

Device Class :

Duns Number: 200103823

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

Rescuer Manual Resuscitator - B0024000UF0 Catalog Number : 4000-U-F

Device Description : Adult manual resuscitator with universal tubing and filter.

Device Class :

Duns Number: 200103823

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

Rescuer BVM Manual Resuscitator - B0024000UP0 Catalog Number : 4000-U-P

Device Description : Adult sized disposable Rescuer BVM Manual Resuscitator with 2900 mL reservoir ba Adult sized disposable Rescuer BVM Manual Resuscitator with 2900 mL reservoir bag, #5 cushion mask, 2 m crush proof oxygen tubing (universal connector) and attached 0-20 cmH2O PEEP valve.

Device Class : 2

Duns Number: 200103823

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

Rescuer BVM Manual Resuscitator - B00240100 Catalog Number : 4010

Device Description : Rescuer Child Size manual resuscitator with 2900 mL reservoir, #3 cushion mask a Rescuer Child Size manual resuscitator with 2900 mL reservoir, #3 cushion mask and 2 m crush proof oxygen tubing (each)

Device Class :

Duns Number: 200103823

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

Rescuer Child BVM Manual Rescusitator - B0024010U0 Catalog Number : 4010U

Device Description : Rescuer disposable Child manual resuscitator with 2900 mL reservoir, #3 cushion Rescuer disposable Child manual resuscitator with 2900 mL reservoir, #3 cushion mask and 2 m crush proof oxygen tubing with universal style connector

Device Class : 2

Duns Number: 200103823

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

Rescuer Manual Resuscitator - B0024010UF0 Catalog Number : 4010-U-F

Device Description : Child Size Rescuer Manual Resuscitator with universal tubing and filter

Device Class : 2

Duns Number: 200103823

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

Rescuer BVM Manual Resuscitator - B0024010UP0 Catalog Number : 4010-U-P

Device Description : Rescuer branded child disposable BVM Manual Resuscitator with 2900 mL reservoir, Rescuer branded child disposable BVM Manual Resuscitator with 2900 mL reservoir, #3 cushion mask, 2 mL crush proof oxygen tubing (universal connector) and attached 0-20 cmH2O PEEP valve

Device Class : 2

Duns Number: 200103823

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

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