SINGLE USE ADULT RESUSCITATOR BALL 1600ML W/POP-OFF , 60cm H2O & MANOMETER PORT

GUDID 04716770244372

BESMED HEALTH BUSINESS CORP.

Pulmonary resuscitator, manual, single-use

• Primary Device ID: 04716770244372
• NIH Device Record Key: 13b752c8-7b8f-4858-ba66-6086e4e83a5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SINGLE USE ADULT RESUSCITATOR BALL 1600ML W/POP-OFF , 60cm H2O & MANOMETER PORT
• Version Model Number: RE-24437
• Company DUNS: 658023775
• Company Name: BESMED HEALTH BUSINESS CORP.
• Device Count: 1
• DM Exempt: true
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04716770244372 [Primary]
GS1	14716770244372 [Package]; Package: PE bag [1 Units]; In Commercial Distribution
GS1	14716770244379 [Package]; Package: carton [24 Units]; In Commercial Distribution
GS1	24716770244372 [Package]; Contains: 14716770244372; Package: carton [24 Units]; In Commercial Distribution
GS1	24716770244376 [Package]; Contains: 14716770244379; Package: carton [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021442

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: 2020-02-04
• Device Publish Date: 2016-05-23

Devices Manufactured by BESMED HEALTH BUSINESS CORP.

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• 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