Reusable Skin Temperature Probes

GUDID 00854401006327

FLEXICARE MEDICAL LIMITED

Electrical probe/electrode conductive pad

• Primary Device ID: 00854401006327
• NIH Device Record Key: 745b7a13-bdab-4a6d-ab72-ce88630a3898
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reusable Skin Temperature Probes
• Version Model Number: NF-024U
• 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854401006327 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123937

FDA Product Code

• FPL: Incubator, Neonatal Transport

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: 2019-06-13
• Device Publish Date: 2019-06-05

On-Brand Devices [Reusable Skin Temperature Probes]

• 00854401006327: NF-024U
• 05055931111146: NF-024U