Aligned Medical Solutions

Basic Information

• Brand Name: Aligned Medical Solutions
• Primary DI: B098AMS2399E0
• Version / Model: AMS2399E
• Catalog Number: AMS2399E
• Company Name: Aligned Medical Solutions
• Labeler DUNS: 106580145
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-26
• Public Version: 1
• Public Version Date: 2023-08-03
• Public Version Status: New
• Public Device Record Key: e938d265-0602-4435-8560-27f961a228c3

Device Description

X-Ray Block Tray

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OGJ	Nerve Block Tray	Anesthesiology	868.5140	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43682	Arbekacin therapeutic drug monitoring IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement and therapeutic monitoring of the antimicrobial drug arbekacin in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B098AMS2399E1	HIBCC	CASE	50	In Commercial Distribution
Primary	B098AMS2399E0	HIBCC

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius