ASTOPAD® DUO310-NA

GUDID 04260114140030

DUO310-NA

Stihler Electronic GmbH

Electric pad whole-body heating system

• Primary Device ID: 04260114140030
• NIH Device Record Key: c4da051d-ff23-4a71-b2cf-c20df6134a5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASTOPAD®
• Version Model Number: DUO310-NA
• Catalog Number: DUO310-NA
• Company DUNS: 317742377
• Company Name: Stihler Electronic GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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	04260114140030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202197

FDA Product Code

• DWJ: System, thermal regulating

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: 2020-10-15
• Device Publish Date: 2020-10-07

On-Brand Devices [ASTOPAD®]

• 04260114140030: DUO310-NA
• 04260114140269: COV180-NA
• 04260114140252: COV155-NA
• 04260114140245: COV150-NA
• 04260114140238: COV105-NA
• 04260114140221: COV070-NA