High Range AED II

Basic Information

• Brand Name: High Range AED II
• Primary DI: B800727400
• Version / Model: 72740
• Catalog Number: 72740
• Company Name: UTAK LABORATORIES, INC.
• Labeler DUNS: 092519016
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-15
• Public Version: 1
• Public Version Date: 2020-04-23
• Public Version Status: New
• Public Device Record Key: 5c59bbfb-bb3f-4b4b-8e27-14d82b7c27d0

Device Description

HR AED II

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DIF	Drug Mixture Control Materials	Clinical Toxicology	862.3280	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61981	Multiple anticonvulsant therapeutic drug monitoring IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement and therapeutic monitoring of multiple anticonvulsant drugs, also known as antiepileptic drugs which may include carbamazepine, lamotrigine, phenytoin, and primidone, in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B800727405	HIBCC	Box	5	In Commercial Distribution
Primary	B800727400	HIBCC

Customer Contacts

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

Storage Conditions

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