Epinephrine

Basic Information

• Brand Name: Epinephrine
• Primary DI: G0561013111
• Version / Model: 101311
• Catalog Number: 101311
• Company Name: Bio/Data Corporation
• Labeler DUNS: 051392959
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-03-23
• Public Version: 1
• Public Version Date: 2022-03-31
• Public Version Status: New
• Public Device Record Key: 051778c7-d13a-410d-b1ef-eb412399abd6

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: No
• PM Exempt: No
• 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
JOZ	System, Automated Platelet Aggregation	Hematology	864.5700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56092	Platelet aggregation study 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 qualitative evaluation of platelet aggregation in a clinical specimen using one or multiple platelet aggregation agents, which may include adenosine diphosphate, collagen, epinephrine, thrombin, arachidonic acid and/or ristocetin.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G0561013111	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K790769	000