Infant Heel Warmer 1223

GUDID 00850018561594

Infant Heel Warmer

INTERNATIONAL BIOMEDICAL, LTD.

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• Primary Device ID: 00850018561594
• NIH Device Record Key: a91123b6-aed8-4c1b-9be2-a35da18f8702
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Infant Heel Warmer
• Version Model Number: 1223
• Catalog Number: 1223
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850018561594 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221154

FDA Product Code

• MPO: Infant Heel Warmer (Chemical Heat Pack)

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

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