ASTOFLO® PLUS ECO AFP300UK

GUDID 04260114140597

Blood and infusion warmer

Stihler Electronic GmbH

Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer

• Primary Device ID: 04260114140597
• NIH Device Record Key: 99b6cef1-d684-4b25-a406-ed65c96d9126
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASTOFLO® PLUS ECO
• Version Model Number: AFP300UK
• Catalog Number: AFP300UK
• 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	04260114140597 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082765

FDA Product Code

• LGZ: Warmer, thermal, infusion fluid

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: 2016-09-07

On-Brand Devices [ASTOFLO® PLUS ECO]

• 04260114140894: Blood and infusion warmer
• 04260114140887: Blood and infusion warmer
• 04260114140702: Heating profile
• 04260114140696: Heating profile
• 04260114140689: Heating profile
• 04260114140672: Heating profile
• 04260114140665: Blood and infusion warmer
• 04260114140658: Blood and infusion warmer
• 04260114140603: Blood and infusion warmer
• 04260114140597: Blood and infusion warmer