Early Bird Bleed Monitoring System

Basic Information

• Brand Name: Early Bird Bleed Monitoring System
• Primary DI: 00866532000419
• Version / Model: FG001-02
• Company Name: SARANAS INC.
• Labeler DUNS: 078299103
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-12-10
• Public Version: 1
• Public Version Date: 2019-12-18
• Public Version Status: New
• Public Device Record Key: b82b12aa-0f79-4dd2-8c0e-506680794a4b

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: MR Unsafe
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QFJ	Intravascular Bleed Monitor	Cardiovascular	870.1345	2

GMDN Terms

Code	Name	Definition	Implantable	Status
15023	Femoral artery/vein access catheter	A thin, flexible tube intended to be surgically inserted into the femoral artery or the femoral vein to provide an alternative access to a patient's vasculature, typically when other access routes are not viable or are exhausted. It may be used for continuous arteriovenous (AV) haemofiltration, the delivery of chemotherapeutic agents, or for other chronic applications to avoid repetitive injections. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00866532000419	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
DEN180021	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			8 French