CONN, STR 3/8" X 3/8" W/LL NO CAP C135E

GUDID B066C135E5

A sterile plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension or shunt; it

NOVOSCI CORP.

Cardiopulmonary bypass system tubing connector Cardiopulmonary bypass system tubing connector Low-pressure tubing connector, single-use, non-sterile Low-pressure tubing connector, single-use, non-sterile Low-pressure tubing connector, single-use, non-sterile Low-pressure tubing connector, single-use, non-sterile Low-pressure tubing connector, single-use, non-sterile Low-pressure tubing connector, single-use, non-sterile Low-pressure tubing connector, single-use, non-sterile Low-pressure tubing connector, single-use, non-sterile Low-pressure tubing connector, single-use, non-sterile Low-pressure tubing connector, single-use, non-sterile Low-pressure tubing connector, single-use, non-sterile Low-pressure tubing connector, single-use, non-sterile Non-ISO80369-standardized small-bore linear connector, single-use Non-ISO80369-standardized small-bore linear connector, single-use Non-ISO80369-standardized small-bore linear connector, single-use Non-ISO80369-standardized small-bore linear connector, single-use Non-ISO80369-standardized small-bore linear connector, single-use Non-ISO80369-standardized small-bore linear connector, single-use Non-ISO80369-standardized small-bore linear connector, single-use Non-ISO80369-standardized small-bore linear connector, single-use Non-ISO80369-standardized small-bore linear connector, single-use Non-ISO80369-standardized small-bore linear connector, single-use Non-ISO80369-standardized small-bore linear connector, single-use Non-ISO80369-standardized small-bore linear connector, single-use Non-ISO80369-standardized small-bore linear connector, single-use Non-ISO80369-standardized small-bore linear connector, single-use Non-ISO80369-standardized small-bore linear connector, single-use Non-ISO80369-standardized small-bore linear connector, single-use Non-ISO80369-standardized small-bore linear connector, single-use
Primary Device IDB066C135E5
NIH Device Record Key08ea95e6-83ec-4b5e-87b2-e623044c7fe9
Commercial Distribution StatusIn Commercial Distribution
Brand NameCONN, STR 3/8" X 3/8" W/LL NO CAP
Version Model NumberC135E
Catalog NumberC135E
Company DUNS938289980
Company NameNOVOSCI CORP.
Device Count200
DM Exemptfalse
Pre-market Exempttrue
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 Datefalse
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
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
HIBCCB066C135E0 [Unit of Use]
HIBCCB066C135E1 [Primary]
HIBCCB066C135E2 [Package]
Contains: B066C135E1
Package: PARTIAL CASE [400 Units]
In Commercial Distribution
HIBCCB066C135E3 [Package]
Contains: B066C135E1
Package: PARTIAL CASE [600 Units]
In Commercial Distribution
HIBCCB066C135E4 [Package]
Contains: B066C135E1
Package: PARTIAL CASE [800 Units]
In Commercial Distribution
HIBCCB066C135E5 [Package]
Contains: B066C135E1
Package: CASE [1000 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KOCAccessories, Blood Circuit, Hemodialysis

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B066C135E5]

Ethylene Oxide

[B066C135E5]

Ethylene Oxide

[B066C135E5]

Ethylene Oxide

[B066C135E5]

Ethylene Oxide

[B066C135E5]

Ethylene Oxide

[B066C135E5]

Ethylene Oxide

[B066C135E5]

Ethylene Oxide

[B066C135E5]

Ethylene Oxide

[B066C135E5]

Ethylene Oxide

[B066C135E5]

Ethylene Oxide

[B066C135E5]

Ethylene Oxide

[B066C135E5]

Ethylene Oxide

[B066C135E5]

Ethylene Oxide

[B066C135E5]

Ethylene Oxide

[B066C135E5]

Ethylene Oxide

[B066C135E5]

Ethylene Oxide

[B066C135E5]

Ethylene Oxide

[B066C135E5]

Ethylene Oxide

[B066C135E5]

Ethylene Oxide

[B066C135E5]

Ethylene Oxide

[B066C135E5]

Ethylene Oxide

[B066C135E5]

Ethylene Oxide

[B066C135E5]

Ethylene Oxide

[B066C135E5]

Ethylene Oxide

[B066C135E5]

Ethylene Oxide

[B066C135E5]

Ethylene Oxide

[B066C135E5]

Ethylene Oxide

[B066C135E5]

Ethylene Oxide

[B066C135E5]

Ethylene Oxide

[B066C135E5]

Ethylene Oxide

[B066C135E5]

Ethylene Oxide

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2015-10-13

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.