NeoPIP Infant Resuscitator

GUDID 00854401006389

FLEXICARE MEDICAL LIMITED

Pulmonary resuscitator, pneumatic, reusable Pulmonary resuscitator, pneumatic, reusable Pulmonary resuscitator, pneumatic, reusable Pulmonary resuscitator, pneumatic, reusable Pulmonary resuscitator, pneumatic, reusable Pulmonary resuscitator, pneumatic, reusable Pulmonary resuscitator, pneumatic, reusable Pulmonary resuscitator, pneumatic, reusable Pulmonary resuscitator, pneumatic, reusable Pulmonary resuscitator, pneumatic, reusable Pulmonary resuscitator, pneumatic, reusable Pulmonary resuscitator, pneumatic, reusable Pulmonary resuscitator, pneumatic, reusable Pulmonary resuscitator, pneumatic, reusable Pulmonary resuscitator, pneumatic, reusable Pulmonary resuscitator, pneumatic, reusable Pulmonary resuscitator, pneumatic, reusable Pulmonary resuscitator, pneumatic, reusable

• Primary Device ID: 00854401006389
• NIH Device Record Key: f1ec34cf-f324-4277-bade-cf619a33d3ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeoPIP Infant Resuscitator
• Version Model Number: NF-100U
• Company DUNS: 504406273
• Company Name: FLEXICARE MEDICAL LIMITED
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854401006389 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072021

FDA Product Code

• BTM: Ventilator, Emergency, Manual (Resuscitator)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-01-11
• Device Publish Date: 2018-12-11

On-Brand Devices [NeoPIP Infant Resuscitator]

• 00854401006389: NF-100U
• 05055931119586: NF-100U