ASTOLINE AL222

GUDID 04260114140443

Active isolation

Stihler Electronic GmbH

Conduction blood/fluid warmer

• Primary Device ID: 04260114140443
• NIH Device Record Key: 756e725d-f14e-41d0-806b-2c9ae4db5648
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASTOLINE
• Version Model Number: AL222
• Catalog Number: AL222
• 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	04260114140443 [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 [ASTOLINE]

• 04260114140450: Active isolation
• 04260114140443: Active isolation