NeoPIP Infant Resuscitator Universal Mounting Bracket

GUDID 05055931119593

FLEXICARE MEDICAL LIMITED

Pulmonary resuscitator, pneumatic, reusable

• Primary Device ID: 05055931119593
• NIH Device Record Key: ac8f0a30-db6e-4c89-8f96-759a31d597a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeoPIP Infant Resuscitator Universal Mounting Bracket
• Version Model Number: NF-101U
• 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	05055931119593 [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: 2023-08-04
• Device Publish Date: 2023-07-27

On-Brand Devices [NeoPIP Infant Resuscitator Universal Mounting Bracket]

• 00854401006396: NF-101U
• 05055931119593: NF-101U