Rescuer BVM Manual Resuscitator 4050-U-P

GUDID B0024050UP3

Rescuer branded adult disposable BVM manual resuscitator with system pressure relif valve, 2900 mL reservoir bag, 2 m crush proof oxygen tubing (universal connector) and attached 0-20 cmH2O PEEP valve

B.L.S. Systems Limited

Pulmonary resuscitator, manual, single-use

• Primary Device ID: B0024050UP3
• NIH Device Record Key: a3e2d443-2aaf-4786-942c-a8aedafb3ee5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rescuer BVM Manual Resuscitator
• Version Model Number: 4050-U-P
• Catalog Number: 4050-U-P
• Company DUNS: 200103823
• Company Name: B.L.S. Systems Limited
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 19053391069
• Email: tedreesor@blssystemsltd.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B0024050UP0 [Primary]
HIBCC	B0024050UP3 [Package]; Contains: B0024050UP0; Package: case [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993194

FDA Product Code

• BTM: Ventilator, Emergency, Manual (Resuscitator)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-04
• Device Publish Date: 2019-10-25

On-Brand Devices [Rescuer BVM Manual Resuscitator]

• B0024050U3: Rescuer disposable adult manual resuscitator with pressure release valve, 2900 ml bag reservoir,
• B00240506: Rescuer disposable adult manual resuscitator with pressure release valve, 2900 mL reservoir, #5
• B0024025U0: Rescuer disposable infant manual resuscitator with 800 mL reservoir, #1 mask, 2m crush proof oxy
• B00240256: Rescuer disposable infant manual resuscitator with 800 mL reservoir, #1 cushion mask and 2 m cru
• B00240100: Rescuer Child Size manual resuscitator with 2900 mL reservoir, #3 cushion mask and 2 m crush pro
• B00240000: Rescuer adult disposable manual resuscitator with 2900 mL reservoir bag, #5 cushion mask and 2 m
• B0024050UP3: Rescuer branded adult disposable BVM manual resuscitator with system pressure relif valve, 2900
• B0024025UP3: Rescuer Infant sized disposable BVM manual resuscitator with 800 mL reservoir bag, #1 cushion ma
• B0024010UP3: Rescuer branded child disposable BVM Manual Resuscitator with 2900 mL reservoir, #3 cushion mask
• B0024000UP3: Adult sized disposable Rescuer BVM Manual Resuscitator with 2900 mL reservoir bag, #5 cushion ma