AIA-PACK SUBSTRATE SET II

Basic Information

• Brand Name: AIA-PACK SUBSTRATE SET II
• Primary DI: 04560189211742
• Version / Model: n/a
• Company Name: TOSOH CORPORATION
• Labeler DUNS: 690571724
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-09-02
• Public Version: 3
• Public Version Date: 2024-02-09
• Public Version Status: Update
• Public Device Record Key: 27c3df4b-9298-4db1-a8e8-599a5c20da10

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
52902	Multiple clinical chemistry enzyme IVD, kit, enzyme fluorescence	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple clinical chemistry enzymes, using an enzyme fluorescence method. Analytes detected may include alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	14560189211749	GS1		2	In Commercial Distribution
Primary	04560189211742	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius