Aortic Sump Set - Adult 201095-000

GUDID B0662010950006

A collection of sterile, flexible, double-bore tubing, and associated items (typically includes clamps, filters, spikes, and connectors), used as twin conduits in a surgical irrigation/aspiration system to deliver irrigation solution to a surgical field through one bore and provide aspiration (suction) through the other during a surgical procedure (e.g., tissue/bone morcellation, ENT, neuro and general surgery). The tubing is made of synthetic material and is of a fixed diameter that may be specific to the requirements of the clinical application for which it is intended. This is a single-use device.

NOVOSCI CORP.

Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set
Primary Device IDB0662010950006
NIH Device Record Key85c2a8b6-7c82-4489-962d-993a5d6fb6b1
Commercial Distribution StatusIn Commercial Distribution
Brand NameAortic Sump Set - Adult
Version Model Number201095-000
Catalog Number201095-000
Company DUNS938289980
Company NameNOVOSCI CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-854-0567
Emailinfo@novosci.com
Phone800-854-0567
Emailinfo@novosci.com
Phone800-854-0567
Emailinfo@novosci.com
Phone800-854-0567
Emailinfo@novosci.com
Phone800-854-0567
Emailinfo@novosci.com
Phone800-854-0567
Emailinfo@novosci.com
Phone800-854-0567
Emailinfo@novosci.com
Phone800-854-0567
Emailinfo@novosci.com
Phone800-854-0567
Emailinfo@novosci.com
Phone800-854-0567
Emailinfo@novosci.com
Phone800-854-0567
Emailinfo@novosci.com
Phone800-854-0567
Emailinfo@novosci.com
Phone800-854-0567
Emailinfo@novosci.com
Phone800-854-0567
Emailinfo@novosci.com
Phone800-854-0567
Emailinfo@novosci.com
Phone800-854-0567
Emailinfo@novosci.com
Phone800-854-0567
Emailinfo@novosci.com
Phone800-854-0567
Emailinfo@novosci.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB0662010950000 [Primary]
HIBCCB0662010950003 [Package]
Contains: B0662010950000
Package: Inner Carton [25 Units]
In Commercial Distribution
HIBCCB0662010950004 [Package]
Contains: B0662010950000
Package: Partial Case [50 Units]
In Commercial Distribution
HIBCCB0662010950005 [Package]
Contains: B0662010950000
Package: Partial Case [75 Units]
In Commercial Distribution
HIBCCB0662010950006 [Package]
Contains: B0662010950000
Package: Case [100 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-04-23
Device Publish Date2016-09-26

Devices Manufactured by NOVOSCI CORP.

B066C345B1 - CONNECTOR, EQUAL Y 1/2" W/LUER2023-07-13 A plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension
B0662010110000 - STOPCOCK, TMP 3-WAY W/LUER LOCK2022-03-10 A general-purpose valve that is used to regulate the direction of a liquid or a gas flow. It is typically constructed of a durab
B0663010100000 - CONNECTOR, 3/8" PERFUSION ADAPTER2022-03-10 A sterile plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an e
B066341111NS1 - CONNECTOR, Y 3/16" x 3/16" x 3/16" W/O LUER2022-03-10 A plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension
B066341222NS1 - CONNECTOR, Y 1/4" X 1/4" X 1/4"2022-03-10 A plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension
B066341344NS5 - CONNECTOR, Y 3/8" x 1/2" x 1/2" W/O LUER2022-03-10 A plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension
B066H11360 - STANDARD VAVD KIT2022-03-10 A collection of sterile devices intended to be used to inject cardioplegia solution into the heart to interrupt its contractions
B0663011240000 - QUICKIE PRIME - 24" W/CLAMP2022-03-09 A sterile, semi-rigid tube used in open heart surgery to facilitate the transfer of priming fluids during the priming of the ext
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.