Little PALS

GUDID 00851913006098

AXELGAARD MANUFACTURING CO., LTD.

Neonatal electrocardiographic electrode

• Primary Device ID: 00851913006098
• NIH Device Record Key: aea7346b-3d0a-4086-8c40-86cda9d17f8c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Little PALS
• Version Model Number: SEN3001
• Company DUNS: 150959401
• Company Name: AXELGAARD MANUFACTURING CO., 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

Customer Support Contacts

• Phone: 760-451-8000
• Email: support@axelgaard.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851913006098 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000206

FDA Product Code

• DRX: Electrode, Electrocardiograph

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-03-31

On-Brand Devices [Little PALS]

• 00851913006111: SEN5001
• 00851913006104: SEN4001
• 00851913006098: SEN3001
• 00851913006081: SEN2002
• 00851913006074: SEN2001
• 00851913006067: SEN1003