FDA.reportPublic FDA data

Exhaust Collection Bag

Primary DI
20850008595022
Brand
Exhaust Collection Bag
Company
CHANNEL MEDSYSTEMS, INC.
Model
FGS-7005
Device description
Single exhaust collection bag in pouch
Published
2020-08-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNBDevice, Thermal Ablation, Endometrial

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNBDevice, Thermal Ablation, EndometrialUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P180032001

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P180032001Cerene® Cryotherapy DeviceChannel Medsystems, Inc.2019-03-28MNB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20850008595022PackageGS110In Commercial Distribution
00850008595028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085000859502220850008595022
00850008595028008500085950288500085950280850008595028

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held cryosurgical systemA hand-held assembly of electrically-powered devices designed to apply cold from a gaseous or liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to skin, subcutaneous, and/or mucosal tissues for cryotherapy applications (e.g., surgical ablation, cosmetic, analgesic). It typically includes a single-use or reusable handpiece with disposable application tip and cryogen cartridge (e.g., N2O cartridge), whereby the cryogen is delivered through the handpiece to the tip which is applied to tissues. It can be used for dedicated applications or across clinical specialties (e.g., general surgery, dermatology, neurology, orthopaedics, gynaecology).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(510) 338-9301support@channelmedsystems.com

Regulatory Flags#

DUNS number
963415513
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850008595035Cerene Cryotherapy DeviceFGS-70002020-08-21
00850008595028Exhaust Collection BagFGS-70052020-08-21
00850008595042Exhaust Collection BagFGS-70152023-04-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888937026870Mara ConsoleCoopersurgical, Inc.MNB2024-03-13
00888937026887Mara Coopersurgical, Inc.MNB2023-12-01
00850044503018MinitouchMicrocube, LLCMNB2023-10-18
00850044503117MinitouchMicrocube, LLCMNB2023-10-18
00850044503124MinitouchMicrocube, LLCMNB2023-10-18
00850044503131MinitouchMicrocube, LLCMNB2023-10-18
00850044503148MinitouchMicrocube, LLCMNB2023-10-18
00850044503155MinitouchMicrocube, LLCMNB2023-10-18
00850044503162MinitouchMicrocube, LLCMNB2023-10-18
00850044503209MinitouchMicrocube, LLCMNB2023-10-18
10850044503015MinitouchMicrocube, LLCMNB2023-10-18
15420045515154NovaSureHologic, Inc.MNB2023-04-22
00850008595042Exhaust Collection BagCHANNEL MEDSYSTEMS, INC.MNB2023-04-06
00850033976014Genesys HTA Control UnitMinerva Surgical, Inc.MNB2022-06-08
00850033976021Genesys HTA Control Unit - RefurbishedMinerva Surgical, Inc.MNB2022-06-08
00850033976038Genesys HTA ProCervaMinerva Surgical, Inc.MNB2022-06-08
15420045514294NovaSureHologic, Inc.MNB2021-07-02
15420045514300NovaSureHologic, Inc.MNB2021-07-02
25420045514307NovaSureHologic, Inc.MNB2021-07-02
00850008595028Exhaust Collection BagCHANNEL MEDSYSTEMS, INC.MNB2020-08-21
00850008595035Cerene Cryotherapy DeviceCHANNEL MEDSYSTEMS, INC.MNB2020-08-21
00857379006023Mara ConsoleAEGEA MEDICAL INC.MNB2020-03-16
00857379006030Mara Water Vapor Probe KitAEGEA MEDICAL INC.MNB2020-03-16
00862393000100Minerva RF ControllerMinerva Surgical, Inc.MNB2017-06-27
00862393000117Minerva Disposable HandpiecesMinerva Surgical, Inc.MNB2017-06-27
00862393000131Minerva Argon Gas Canister (5 pack)Minerva Surgical, Inc.MNB2017-06-27
00862393000148Minerva Co2 CanistersMinerva Surgical, Inc.MNB2017-06-27
00862393000155Minerva DesiccantMinerva Surgical, Inc.MNB2017-06-27
00862393000162Minerva Single Sterile Disposable HandpieceMinerva Surgical, Inc.MNB2017-06-27
00862393000179Minerva Hegar Dilator (3 Pack)Minerva Surgical, Inc.MNB2017-06-27