FDA.reportPublic FDA data

ClearMate

Primary DI
10807141000107
Brand
ClearMate
Company
Thornhill Research Inc
Model
128222
Device description
Assy, ClearMate, DISS, US
Published
2020-10-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
10807141000107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1080714100010710807141000107

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
1-888-597-1325info@thornhillmedical.com

Regulatory Flags#

DUNS number
205151975
Device count
1
Serial number
true

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
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
18071411282223ClearMate1282222019-06-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18071411282223ClearMateThornhill Research IncQFB2019-06-07