SILICONE ADULT 1000ML RESUSCITATOR W/O POP-OFF

GUDID 04716770231228

BESMED HEALTH BUSINESS CORP.

Pulmonary resuscitator, pneumatic, reusable

• Primary Device ID: 04716770231228
• NIH Device Record Key: b88b2705-a30d-4a4f-ac35-3b6a58761967
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SILICONE ADULT 1000ML RESUSCITATOR W/O POP-OFF
• Version Model Number: RE-23122
• Company DUNS: 658023775
• Company Name: BESMED HEALTH BUSINESS CORP.
• 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: false
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04716770231228 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021446

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-05-23

Devices Manufactured by BESMED HEALTH BUSINESS CORP.

• 04716770701127 - HME W/Luer lock port (Dead space 45ml): 2026-02-19 HME W/Luer lock port (Dead space 45ml)
• 04716770701158 - Angled HME with luer lock port: 2026-02-19 Angled HME with luer lock port
• 04716770702230 - Bacterial Filter (Dead space 32ml): 2026-02-19 Bacterial Filter (Dead space 32ml)
• 14716770703029 - HMEF W/Luer lock port (Dead space 45ml): 2026-02-19 HMEF W/Luer lock port (Dead space 45ml)
• 14716770703036 - HMEF W/Luer lock port (Dead space 60ml): 2026-02-19 HMEF W/Luer lock port (Dead space 60ml)
• 14716770703067 - HMEF (Dead space 60ml): 2026-02-19 HMEF (Dead space 60ml)
• 04716770834221 - ICU gas sampling pack: 2022-08-16 OEM ref: C05096-01-11
• 04716770834238 - ICU gas sampling pack with flowmeter: 2022-08-16 OEM ref: C05096-02-11