FDA.reportPublic FDA data

MOVES SLC

Primary DI
10807141000114
Brand
MOVES SLC
Company
Thornhill Research Inc
Model
124846
Device description
ASSY, MOVES SLC System in Case
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
BTAPump, Portable, Aspiration (Manual Or Powered)
BTLVentilator, Emergency, Powered (Resuscitator)
CAWGenerator, Oxygen, Portable
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTAPump, Portable, Aspiration (Manual Or Powered)General, Plastic Surgery2
BTLVentilator, Emergency, Powered (Resuscitator)Anesthesiology2
CAWGenerator, Oxygen, PortableAnesthesiology2
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161420000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161420000MOVES SLCThornhill Research, Inc.2017-06-06BTL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10807141000114PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1080714100011410807141000114

GMDN Terms#

Term, Definition table
TermDefinition
Portable electric ventilatorA portable, electrically-powered device intended to provide long-term alveolar support for patients who do not require complex critical care ventilation. It typically uses positive pressure to deliver gas to the lungs at normal breathing rates and tidal volumes through invasive ventilation (i.e., with an artificial airway); it may also be used non-invasively (e.g., with a mask). It includes a control system and alarms, and may include a built-in humidifier. Several methods of cycling and ventilation modes may be used. It may be line and/or internal/external battery-powered for use in the home or a healthcare facility (including ambulatory).

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
10807141000107ClearMate1282222020-10-01
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

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Primary DI, Brand, Company table
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