ETHANOL 120 MG/DL

Basic Information

• Brand Name: ETHANOL 120 MG/DL
• Primary DI: B800ETH120UTCRFL0
• Version / Model: ETH 120 U TCRFL
• Catalog Number: ETH 120 U TCRFL
• Company Name: UTAK LABORATORIES, INC.
• Labeler DUNS: 092519016
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-12
• Public Version: 1
• Public Version Date: 2023-01-20
• Public Version Status: New
• Public Device Record Key: 5372c813-d2af-4664-863d-256cf04dc62e

Device Description

ETHANOL 120 MG/DL

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
LAS	Drug Specific Control Materials	Clinical Toxicology	862.3280	1

GMDN Terms

Code	Name	Definition	Implantable	Status
55611	Ethanol (ETOH) IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of ethyl alcohol (ETOH) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B800ETH120UTCRFL0	HIBCC
Package	B800ETH120UTCRFL5	HIBCC	Box	64	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	3	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – -10 Degrees Celsius