Neo-Vent Infant T-Piece Resuscitation Circuit w/Neonatal Mask

GUDID 10709078000659

Neo-Vent Infant T-Piece Resuscitation Circuit w/Neonatal Mask

WESTMED, INC.

Pulmonary resuscitator, manual, single-use

• Primary Device ID: 10709078000659
• NIH Device Record Key: 721576e1-4591-405f-ba9c-de990a03134f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neo-Vent Infant T-Piece Resuscitation Circuit w/Neonatal Mask
• Version Model Number: 0421
• 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: false
• 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	00709078000652 [Primary]
GS1	10709078000659 [Package]; Contains: 00709078000652; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K923618

FDA Product Code

• BYE: Attachment, Breathing, Positive End Expiratory Pressure

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-12-14

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