ASTOTHERM® PLUS AP220AU

GUDID 04260114140955

Blood and infusion warmer

Stihler Electronic GmbH

Conduction blood/fluid warmer

• Primary Device ID: 04260114140955
• NIH Device Record Key: a702d78f-bc22-499d-80de-f938fc3b005d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASTOTHERM® PLUS
• Version Model Number: AP220AU
• Catalog Number: AP220AU
• Company DUNS: 317742377
• Company Name: Stihler Electronic GmbH
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260114140955 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991160

FDA Product Code

• BSB: Warmer, blood, non-electromagnetic radiation

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: 2016-08-31

On-Brand Devices [ASTOTHERM® PLUS]

• 04260114140955: Blood and infusion warmer
• 04260114140931: Blood and infusion warmer
• 04260114140924: Blood and infusion warmer
• 04260114140917: Blood and infusion warmer
• 04260114140900: Blood and infusion warmer
• 04260114140528: Blood and infusion warmer
• 04260114140481: Blood and infusion warmer
• 04260114140474: Blood and infusion warmer
• 04260114140467: Blood and infusion warmer
• 04260114140405: Blood and infusion warmer
• 04260114140399: Blood and infusion warmer
• 04260114140382: Blood and infusion warmer
• 04260114140375: Blood and infusion warmer