Early Bird Bleed Monitoring System

GUDID 00866532000402

SARANAS INC.

Femoral artery/vein access catheter
Primary Device ID00866532000402
NIH Device Record Key331bb107-c044-47b1-aed2-94beb2eb6cb0
Commercial Distribution StatusIn Commercial Distribution
Brand NameEarly Bird Bleed Monitoring System
Version Model NumberFG001-01
Company DUNS078299103
Company NameSARANAS INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone18333759273
Email[email protected]

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100866532000402 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QFJIntravascular Bleed Monitor

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-12-11
Device Publish Date2019-11-19

On-Brand Devices [Early Bird Bleed Monitoring System]

00866532000402FG001-01
00866532000419FG001-02

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