Aldahol 1.8

GUDID 00857635006040

ALDEN MEDICAL LLC

Glutaraldehyde device sterilant
Primary Device ID00857635006040
NIH Device Record Key90609dac-4efc-4f00-ad45-450e09125a18
Commercial Distribution StatusIn Commercial Distribution
Brand NameAldahol 1.8
Version Model Number4 x 1 gallon case
Company DUNS618196968
Company NameALDEN MEDICAL LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100857635006040 [Primary]
GS100868956000235 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MEDSterilant, Medical Devices

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-22
Device Publish Date2025-09-12

Devices Manufactured by ALDEN MEDICAL LLC

00857635006040 - Aldahol 1.82025-09-22
00857635006040 - Aldahol 1.82025-09-22
00857635006026 - PerAldecide2018-10-01 GALLON BOTTLE WITH 3 LITERS OF PRODUCT

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