Exhaust Collection Bag

GUDID 00850008595042

Exhaust Collection Bag, S1 (single bag in pouch with IFU), accessory to Cerene Cryotherapy Device

CHANNEL MEDSYSTEMS, INC.

General cryosurgical system, cryogen gas, electronic
Primary Device ID00850008595042
NIH Device Record Keyc80d6745-a773-4ffc-ba44-eb8a6c636029
Commercial Distribution StatusIn Commercial Distribution
Brand NameExhaust Collection Bag
Version Model NumberFGS-7015
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+1-510-338-9301
Emailsupport@cerene.com
Phone+1-510-338-9301
Emailsupport@cerene.com
Phone+1-510-338-9301
Emailsupport@cerene.com
Phone+1-510-338-9301
Emailsupport@cerene.com
Phone+1-510-338-9301
Emailsupport@cerene.com
Phone+1-510-338-9301
Emailsupport@cerene.com
Phone+1-510-338-9301
Emailsupport@cerene.com
Phone+1-510-338-9301
Emailsupport@cerene.com
Phone+1-510-338-9301
Emailsupport@cerene.com
Phone+1-510-338-9301
Emailsupport@cerene.com
Phone+1-510-338-9301
Emailsupport@cerene.com
Phone+1-510-338-9301
Emailsupport@cerene.com
Phone+1-510-338-9301
Emailsupport@cerene.com
Phone+1-510-338-9301
Emailsupport@cerene.com

Operating and Storage Conditions

Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100850008595042 [Primary]

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 Date2023-04-14
Device Publish Date2023-04-06

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

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