1/2'' x 1/2'' Straight Connector w/L.L. C-682

GUDID 16641670004601

This device is intended for use during cardiopulmonary bypass in conjunction with other medically approved devices and equipment that are utilized for this procedure.

Cardiomed Supplies Inc

Low-pressure tubing connector, single-use, sterile
Primary Device ID16641670004601
NIH Device Record Key4f3aaf57-87ce-42d9-bf78-bcae35161eb3
Commercial Distribution StatusIn Commercial Distribution
Brand Name1/2'' x 1/2'' Straight Connector w/L.L.
Version Model Number2.8
Catalog NumberC-682
Company DUNS240623124
Company NameCardiomed Supplies Inc
Device Count50
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS116641670004601 [Unit of Use]
GS136641670004612 [Primary]

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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-10
Device Publish Date2020-12-02

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16641670004205 - 3/8'' x 1/4'' x 1/4'' Y Connector2020-12-10 This device is intended for use during cardiopulmonary bypass in conjunction with other medically approved devices and equipment

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