Aldahol 1.8

GUDID 00857635006040

ALDEN MEDICAL LLC

Glutaraldehyde device sterilant

• Primary Device ID: 00857635006040
• NIH Device Record Key: 90609dac-4efc-4f00-ad45-450e09125a18
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aldahol 1.8
• Version Model Number: 4 x 1 gallon case
• Company DUNS: 618196968
• Company Name: ALDEN MEDICAL LLC
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00857635006040 [Primary]
GS1	00868956000235 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113015

FDA Product Code

• MED: Sterilant, Medical Devices

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: 2025-09-22
• Device Publish Date: 2025-09-12

Devices Manufactured by ALDEN MEDICAL LLC

• 00857635006040 - Aldahol 1.8: 2025-09-22
• 00857635006040 - Aldahol 1.8: 2025-09-22
• 00857635006026 - PerAldecide: 2018-10-01 GALLON BOTTLE WITH 3 LITERS OF PRODUCT