Puffin Lite Infant Resuscitator

GUDID 00865648000344

Puffin Lite Infant Resuscitator

INTERNATIONAL BIOMEDICAL, LTD.

Pulmonary resuscitator, pneumatic, reusable

• Primary Device ID: 00865648000344
• NIH Device Record Key: 1254ea27-1fad-4551-a0f0-0321510fd14d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Puffin Lite Infant Resuscitator
• Version Model Number: Puffin
• Company DUNS: 073179368
• Company Name: INTERNATIONAL BIOMEDICAL, LTD.
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 5128730033
• Email: sales@int-bio.com
• Phone: 5128730033
• Email: sales@int-bio.com
• Phone: 5128730033
• Email: sales@int-bio.com
• Phone: 5128730033
• Email: sales@int-bio.com
• Phone: 5128730033
• Email: sales@int-bio.com
• Phone: 5128730033
• Email: sales@int-bio.com
• Phone: 5128730033
• Email: sales@int-bio.com
• Phone: 5128730033
• Email: sales@int-bio.com
• Phone: 5128730033
• Email: sales@int-bio.com
• Phone: 5128730033
• Email: sales@int-bio.com
• Phone: 5128730033
• Email: sales@int-bio.com
• Phone: 5128730033
• Email: sales@int-bio.com
• Phone: 5128730033
• Email: sales@int-bio.com
• Phone: 5128730033
• Email: sales@int-bio.com
• Phone: 5128730033
• Email: sales@int-bio.com
• Phone: 5128730033
• Email: sales@int-bio.com
• Phone: 5128730033
• Email: sales@int-bio.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00865648000344 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182956

FDA Product Code

• BTL: Ventilator, Emergency, Powered (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: 2023-06-28
• Device Publish Date: 2023-06-20

Devices Manufactured by INTERNATIONAL BIOMEDICAL, LTD.

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• 00850018561204 - LC Accu-Bar Temperature Trend Indicator: 2023-06-28 Temperature Trend Indicator
• 00850018561594 - Infant Heel Warmer: 2023-06-28 Infant Heel Warmer
• 00850018561600 - Infant Heel Snuggler: 2023-06-28 Infant Heel Snuggler
• 00850018561648 - NeoPod T, Neonatal Transport Humidification System: 2023-06-28 Neonatal Transport Humidification System
• 00865648000306 - Aviator Transport Incubator: 2023-06-28 Aviator Transport Incubator
• 00865648000313 - NuBorne Infant Warmer: 2023-06-28 NuBorne Infant Warmer