Rescuer BVM Manual Resuscitator with Universal Tub 4000U

GUDID B0024000U0

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

B.L.S. Systems Limited

Pulmonary resuscitator, manual, single-use

• Primary Device ID: B0024000U0
• NIH Device Record Key: 08e31556-cad0-470c-8234-48a051559f7e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rescuer BVM Manual Resuscitator with Universal Tub
• Version Model Number: 4000U
• Catalog Number: 4000U
• 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: 905 339 1069
• Email: tedreesor@blssystemsltd.com
• Phone: 905 339 1069
• Email: tedreesor@blssystemsltd.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B0024000U0 [Primary]
HIBCC	B0024000U3 [Package]; Package: Case of 12 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-13

Devices Manufactured by B.L.S. Systems Limited

• B0024050RB7 - Rescuer: 2024-06-20 Replacement reservoir bag (2.9L) for 4000 series manual resuscitator
• B0023000X7 - Rescuer: 2023-12-19 Rescuer CPR Shield with gloves
• B0026200U0 - Rescuer O-Mask: 2021-04-09 Rescuer O-Mask with Universal Tubing (Large Adult)
• B0026205U7 - Rescuer O-Mask with Universal Oxygen Tubing (Small Adult): 2021-04-09 Rescuer O-Mask with Universal Oxygen Tubing (Small Adult)
• B0026210U7 - Rescuer O-Mask Oxygen Mask with Universal Tubing: 2021-04-09 Rescuer O-Mask Oxygen Mask with Universal Tubing (Child)
• B0024000F0 - Rescuer: 2021-01-18 HEPA Filter component for Rescuer BVM Manual Resuscitator (Emergency Manual Ventilator)
• 00627843557524 - RUSCH: 2020-01-17 Blue RUSCH branded adult manual resuscitator, oxygen reservoir tubing, swivel connector, medication port, Peep connector and med
• 00627843557531 - RUSCH: 2020-01-17 Blue RUSCH branded Adult sized manual resuscitator , oxygen reservoir bag, swivel connector, medication port, PEEP connector and