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

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

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,

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

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

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

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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