SINGLE USE INFANT 280ML RESUSCITATOR W/ POP-OFF 40

GUDID 04716770226156

BESMED HEALTH BUSINESS CORP.

Pulmonary resuscitator, manual, single-use

• Primary Device ID: 04716770226156
• NIH Device Record Key: 36818a08-a18f-42fc-a623-f82ebf04d321
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SINGLE USE INFANT 280ML RESUSCITATOR W/ POP-OFF 40
• Version Model Number: RE-22615
• 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: 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	04716770226156 [Primary]

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

On-Brand Devices [SINGLE USE INFANT 280ML RESUSCITATOR W/ POP-OFF 40]

• 04716770256108: RE-25610
• 04716770246239: RE-24623
• 04716770246222: SINGLE USE INFANT 280ML RESUSCITATOR W/ POP-OFF 40CM H2O,L TYPE ADAPTER WITH MANOMETER POR
• 04716770246208: RE-24620
• 04716770246109: RE-24610
• 04716770236209: RE-23620
• 04716770226156: RE-22615