ASTOTUBE®

GUDID 04260114141396

DEHP-free

Stihler Electronic GmbH

Intravenous administration tubing extension set

• Primary Device ID: 04260114141396
• NIH Device Record Key: 78b5d31a-ddb6-4143-9d55-952c74923dbb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASTOTUBE®
• Version Model Number: M77460002
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry / Keep away from sunlight / do not reuse / do not resterilize / do not use if the packaging is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry / Keep away from sunlight / do not reuse / do not resterilize / do not use if the packaging is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry / Keep away from sunlight / do not reuse / do not resterilize / do not use if the packaging is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry / Keep away from sunlight / do not reuse / do not resterilize / do not use if the packaging is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry / Keep away from sunlight / do not reuse / do not resterilize / do not use if the packaging is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry / Keep away from sunlight / do not reuse / do not resterilize / do not use if the packaging is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry / Keep away from sunlight / do not reuse / do not resterilize / do not use if the packaging is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry / Keep away from sunlight / do not reuse / do not resterilize / do not use if the packaging is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry / Keep away from sunlight / do not reuse / do not resterilize / do not use if the packaging is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry / Keep away from sunlight / do not reuse / do not resterilize / do not use if the packaging is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry / Keep away from sunlight / do not reuse / do not resterilize / do not use if the packaging is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry / Keep away from sunlight / do not reuse / do not resterilize / do not use if the packaging is damaged

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260114141396 [Package]; Contains: 04260114141440; Package: [50 Units]; In Commercial Distribution
GS1	04260114141440 [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: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-26
• Device Publish Date: 2024-08-16

On-Brand Devices [ASTOTUBE®]

• 04260114140436: PVC infusion extension
• 04260114140429: PVC infusion extension
• 04260114140412: PVC infusion extension
• 04260114140016: PVC infusion extension
• 04260114141396: DEHP-free
• 04260114141389: PVC infusion extension