4308 LEVEL 1

Basic Information

• Brand Name: 4308 LEVEL 1
• Primary DI: B80003716500010
• Version / Model: 430806C08
• Company Name: UTAK LABORATORIES, INC.
• Labeler DUNS: 092519016
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-04-25
• Public Version: 1
• Public Version Date: 2022-05-03
• Public Version Status: New
• Public Device Record Key: 31cf0948-cc43-4e1d-b180-ad56d0241847

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
30503	Multiple therapeutic drugs/drugs of abuse IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of multiple therapeutic drugs and drugs of abuse in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B80003716500010	HIBCC
Package	B80003716500011	HIBCC	Box	4	In Commercial Distribution
Package	B80003716500012	HIBCC	Box	5	In Commercial Distribution
Package	B80003716500013	HIBCC	Box	10	In Commercial Distribution
Package	B80003716500016	HIBCC	Box	25	In Commercial Distribution
Package	B80003716500017	HIBCC	Box	50	In Commercial Distribution
Package	B80003716500018	HIBCC	Box	100	In Commercial Distribution

Customer Contacts

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