SINGLE USE ADULT 1000ML RESUSCITATOR W/O POP-OFF

GUDID 04716770000183

BESMED HEALTH BUSINESS CORP.

Pulmonary resuscitator, manual, single-use

• Primary Device ID: 04716770000183
• NIH Device Record Key: 1b561fc4-f19c-4694-9d52-9a88c5e10b68
• Commercial Distribution Discontinuation: 2020-02-05
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: SINGLE USE ADULT 1000ML RESUSCITATOR W/O POP-OFF
• Version Model Number: RE-23412
• 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	04716770000183 [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: 5
• Public Version Date: 2020-02-05
• Device Publish Date: 2016-05-23

On-Brand Devices [ SINGLE USE ADULT 1000ML RESUSCITATOR W/O POP-OFF]

• 40716770234120: RE-23412
• 04716770000183: RE-23412