Fisherbrand

Basic Information

• Brand Name: Fisherbrand
• Primary DI: 00613647025284
• Version / Model: FH2465-605
• Catalog Number: 23001179
• Company Name: FISHER SCIENTIFIC COMPANY L.L.C.
• Labeler DUNS: 004321519
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2023-06-20
• Public Version: 1
• Public Version Date: 2023-06-28
• Public Version Status: New
• Public Device Record Key: 1bd1c382-bc31-4da3-bbd0-5a7c6886735b

Device Description

BHB BI-LEVEL CONTROL

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• 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
53333	Beta-hydroxybutyrate IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of beta-hydroxybutyrate (3-hydroxybutyric acid) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20613647025288	GS1	pack	1	In Commercial Distribution
Primary	00613647025284	GS1
Unit of Use	10613647025281	GS1

Customer Contacts

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