Exhaust Collection Bag

GUDID 20850008595022

Single exhaust collection bag in pouch

CHANNEL MEDSYSTEMS, INC.

Hand-held cryosurgical system
Primary Device ID20850008595022
NIH Device Record Keyd8b2c460-d55a-4dfd-b004-47bba345dbb1
Commercial Distribution StatusIn Commercial Distribution
Brand NameExhaust Collection Bag
Version Model NumberFGS-7005
Company DUNS963415513
Company NameCHANNEL MEDSYSTEMS, INC.
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(510) 338-9301
Emailsupport@channelmedsystems.com
Phone(510) 338-9301
Emailsupport@channelmedsystems.com
Phone(510) 338-9301
Emailsupport@channelmedsystems.com
Phone(510) 338-9301
Emailsupport@channelmedsystems.com
Phone(510) 338-9301
Emailsupport@channelmedsystems.com
Phone(510) 338-9301
Emailsupport@channelmedsystems.com
Phone(510) 338-9301
Emailsupport@channelmedsystems.com
Phone(510) 338-9301
Emailsupport@channelmedsystems.com
Phone(510) 338-9301
Emailsupport@channelmedsystems.com
Phone(510) 338-9301
Emailsupport@channelmedsystems.com
Phone(510) 338-9301
Emailsupport@channelmedsystems.com
Phone(510) 338-9301
Emailsupport@channelmedsystems.com
Phone(510) 338-9301
Emailsupport@channelmedsystems.com
Phone(510) 338-9301
Emailsupport@channelmedsystems.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850008595028 [Primary]
GS120850008595022 [Package]
Contains: 00850008595028
Package: Box of 10 [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNBDevice, Thermal Ablation, Endometrial

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-31
Device Publish Date2020-08-21

On-Brand Devices [Exhaust Collection Bag]

20850008595022Single exhaust collection bag in pouch
00850008595042Exhaust Collection Bag, S1 (single bag in pouch with IFU), accessory to Cerene Cryotherapy Devic

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.