Cool-Cap 60010-US

GUDID 00382830016308

OLYMPIC COOL CAP - US

NATUS MEDICAL INCORPORATED

Circulating-fluid whole-body cooling system control unit Circulating-fluid whole-body cooling system control unit External circulating-fluid core temperature regulation system control unit, cooling-only External circulating-fluid core temperature regulation system control unit, cooling-only External circulating-fluid core temperature regulation system control unit, cooling-only External circulating-fluid core temperature regulation system control unit, cooling-only External circulating-fluid core temperature regulation system control unit, cooling-only External circulating-fluid core temperature regulation system control unit, cooling-only External circulating-fluid core temperature regulation system control unit, cooling-only External circulating-fluid core temperature regulation system control unit, cooling-only External circulating-fluid core temperature regulation system control unit, cooling-only External circulating-fluid core temperature regulation system control unit, cooling-only External circulating-fluid core temperature regulation system control unit, cooling-only External circulating-fluid core temperature regulation system control unit, cooling-only External circulating-fluid core temperature regulation system control unit, cooling-only External circulating-fluid core temperature regulation system control unit, cooling-only External circulating-fluid core temperature regulation system control unit, cooling-only External circulating-fluid core temperature regulation system control unit, cooling-only

• Primary Device ID: 00382830016308
• NIH Device Record Key: 1420bb96-e049-469d-9b5b-caf52a9803b3
• Commercial Distribution Discontinuation: 2014-09-15
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Cool-Cap
• Version Model Number: 60010-US
• Catalog Number: 60010-US
• Company DUNS: 962519208
• Company Name: NATUS MEDICAL INCORPORATED
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382830016308 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P040025

FDA Product Code

• MXM: Cap,Cooling (Infants)

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: 2014-09-15

On-Brand Devices [Cool-Cap]

• 00382830016308: OLYMPIC COOL CAP - US
• 00382830009584: COOLING CAP SET, LARGE SIZE, INT
• 00382830009577: COOLING CAP SET, MEDIUM SIZE, INT
• 00382830009560: COOLING CAP SET, SMALL SIZE, INT
• 00382830004169: TEMPERATURE SENSOR SET