Early Bird Bleed Monitoring System

Primary DI
00866532000419
Brand
Early Bird Bleed Monitoring System
Company
SARANAS INC.
Model
FG001-02
Published
2019-12-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QFJIntravascular Bleed Monitor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QFJIntravascular Bleed MonitorCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN180021000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN180021000Early Bird Bleed Monitoring SystemSaranas, Inc.2019-03-01QFJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00866532000419PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00866532000419008665320004198665320004190866532000419

GMDN Terms#

Term, Definition table
TermDefinition
Femoral artery/vein access catheterA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18333759273info@saranas.com

Regulatory Flags#

DUNS number
078299103
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00866532000402Early Bird Bleed Monitoring SystemFG001-012019-11-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00866532000402Early Bird Bleed Monitoring SystemSARANAS INC.QFJ2019-11-19