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

Ventilator, Emergency, Manual (Resuscitator) (BTM) (6) Mask, Gas, Anesthetic (BSJ) (3) Valve, Non-Rebreathing (CBP) (1)

Premarket Exempt

No Yes

Clear

RUSCH - 00627843557524 Catalog Number : 157100100

Device Description : Blue RUSCH branded adult manual resuscitator, oxygen reservoir tubing, swivel co Blue RUSCH branded adult manual resuscitator, oxygen reservoir tubing, swivel connector, medication port, Peep connector and medium mask

Device Class :

Duns Number: 200103823

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

RUSCH - 00627843557531 Catalog Number : 157100300

Device Description : Blue RUSCH branded Adult sized manual resuscitator , oxygen reservoir bag, swive Blue RUSCH branded Adult sized manual resuscitator , oxygen reservoir bag, swivel connector, medication port, PEEP connector and medium mask.

Device Class :

Duns Number: 200103823

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

RUSCH - 00627843557548 Catalog Number : 157300100

Device Description : Blue RUSCH brand pediatric manual pulmonary resuscitator, oxygen reservoir bag, Blue RUSCH brand pediatric manual pulmonary resuscitator, oxygen reservoir bag, swivel connector, medication port, Peep connector and small mask

Device Class :

Duns Number: 200103823

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

RUSCH - 00627843557555 Catalog Number : 157300300

Device Description : Blue RUSCH branded pediatric manual resuscitator, oxygen reservoir tubing, swive Blue RUSCH branded pediatric manual resuscitator, oxygen reservoir tubing, swivel connector, medication port, Peep connector and small mask

Device Class :

Duns Number: 200103823

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

RUSCH - 00627843557562 Catalog Number : 157400100

Device Description : Blue RUSCH branded infant manual resuscitator, oxygen reservoir bag, swivel conn Blue RUSCH branded infant manual resuscitator, oxygen reservoir bag, swivel connector, medication port, Peep connector and infant mask.

Device Class :

Duns Number: 200103823

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

RUSCH - 00627843557579 Catalog Number : 157400300

Device Description : Blue RUSCH branded infant manual resuscitator, oxygen reservoir tubing, swivel c Blue RUSCH branded infant manual resuscitator, oxygen reservoir tubing, swivel connector, medication port, Peep connector and infant mask.

Device Class :

Duns Number: 200103823

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

Facemask with one way valve in hard shell carrying case - B002000CC0 Catalog Number : 2025

Device Description : Rescuer disposable 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

Rescuer Disposable Resuscitation Cushion Mask (#6 Adult) - B00215000 Catalog Number : 1500

Device Description : Rescuer Disposable Resuscitation Cushion Mask (#6 Adult)

Device Class : 1

Duns Number: 200103823

Premarket Exempt : Yes

Product Code : BSJ

Prescription Use : Yes

Device Count : 1

Rescuer Disposable Resuscitator Cushion Mask (#5 Adult) - B00215050 Catalog Number : 1505

Device Description : Rescuer Disposable Resuscitator Cushion Mask (#5 Adult)

Device Class : 1

Duns Number: 200103823

Premarket Exempt : Yes

Product Code : BSJ

Prescription Use : Yes

Device Count : 1

Rescuer Disposable Resuscitation Cushion Mask (#4 Adult) - B00215060 Catalog Number : 1506

Device Description : Rescuer Disposable Resuscitation Cushion Mask (#4 Adult

Device Class : 1

Duns Number: 200103823

Premarket Exempt : Yes

Product Code : BSJ

Prescription Use : Yes

Device Count : 1

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