ClearMate

Primary DI
18071411282223
Brand
ClearMate
Company
Thornhill Research Inc
Model
128222
Device description
ClearMate TM is intended to be used by emergency department medical professionals as an adjunctive treatment for patients suffering from carbon monoxide poisoning. The use of ClearMate TM enables accelerated elimination of carbon monoxide from the body by allowing isocapnic hyperventilation through simulated partial rebreathing.
Published
2019-06-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
QFBIsocapnic Ventilation Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QFBIsocapnic Ventilation DeviceGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN170044000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN170044000ClearMateThornhill Research, Inc.2019-03-14QFB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18071411282001PackageGS11In Commercial Distribution
18071411282223PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1807141128200118071411282001
1807141128222318071411282223

GMDN Terms#

Term, Definition table
TermDefinition
Oxygen/air breathing gas mixer, emergencyA portable mechanical device designed to mix air and oxygen (O2) for mobile O2 administration during first aid or emergency situations. It is a hand-held compact unit designed to be connected to an O2 gas container and includes an O2/air mixing valve, a filter for the removal of exhaled carbon dioxide (CO2), a bag for exhaled gas collection and recycling (rebreathing functionality), and connectors (e.g., for attachment to a breathing mask). This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-416-597-1325info@thornhillmedical.com

Regulatory Flags#

DUNS number
205151975
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10807141000022MOVES1012102020-10-01
10807141000046MOVES1012112020-10-01
10807141000008MOVES1006952020-10-01
10807141000015MOVES1006962020-10-01
10807141000060MOVES1115592020-10-01
10807141000077MOVES1115602020-10-01
10807141000084MOVES1242412020-10-01
10807141000091MADM1246412020-10-01
10807141000107ClearMate1282222020-10-01
10807141000114MOVES SLC1248462020-10-01
10807141000121MOVES SLC1248472020-10-01
10807141000138MOVES1008232020-10-01
10807141000145MOVES1114222020-10-01
10807141000152MOVES1006262020-10-01
10807141000169MOVES1006272020-10-01
20807141000036MOVES1012102020-10-01
20807141000050MOVES1012112020-10-01
18071411242418MOVES1242412015-11-06
18071411243521MOVES1012102015-11-06
18071411243538MOVES1012112015-11-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10807141000107ClearMateThornhill Research IncQFB2020-10-01