BagEasy

GUDID 00709078562112

Neonatal/Infant Resuscitator w/Peep and Mask, AMBU Disposable Manometer

WESTMED, INC.

Pulmonary resuscitator, manual, single-use

• Primary Device ID: 00709078562112
• NIH Device Record Key: 5785f5e7-6729-4bb1-8506-8c809bdd45a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BagEasy
• Version Model Number: 562111DM
• Company DUNS: 092673953
• Company Name: WESTMED, INC.
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00709078562112 [Primary]
GS1	20709078562116 [Package]; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K940581

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: 2015-10-24

On-Brand Devices [BagEasy]

• 20709078622377: Infant Resuscitator w/Peep and Series 800 Mask
• 20709078622360: Child Resuscitator w/Small Adult and Pediatic Facemask
• 20709078622353: Adult, Resuscitator w/Peep and Series 800 Mask
• 20709078622346: Adult, Resuscitator w/Peep and Mask, 14' O2 Tubing
• 20709078622339: Adult, Resuscitator w/Mask, Peep and CO2 Easy
• 20709078622032: Child Resuscitator w/Peep and Mask, AMBU Disposable Manometer
• 20709078622001: Adult Resuscitator w/Peep and Mask, (Uncollapsed)
• 20709078621905: Infant Resuscitator, w/Peep and Mask, AMBU Disposable Manometer
• 20709078621363: Adult Resuscitator w/Mask and CO2 Easy
• 20709078621332: Child Resuscitator w/Peep, Large and Regular Mask
• 00709078621116: Neonatal/Infant Resuscitator, w/Peep and Mask
• 20709078620861: Infant Resuscitator w/Mask
• 20709078620847: Infant Resuscitator w/Peep and Mask
• 20709078620823: Child Resuscitator w/Pediatric Mask
• 20709078620816: Child Resuscitator w/Peep
• 00709078620805: Child Resuscitator w/Peep and Mask
• 20709078620489: Adult BagEasy Resuscitator w/Peep and Mask
• 00709078620416: Adult BagEasy Resuscitator
• 00709078620409: Adult BagEasy Resuscitator w/Peep
• 00709078620133: Adult BagEasy Resuscitator w/Mask
• 00709078562112: Neonatal/Infant Resuscitator w/Peep and Mask, AMBU Disposable Manometer
• 20709078048368: Adult Resuscitator w/Peep and Mask, Disposible Manometer
• 10709078008075: BagEasy Adult Resucitator w/PEEP, CO2 Port Mask
• 10709078008068: BagEasy, Adult Resuscitator, W/Mask (Uncollapsed)