FDA.reportPublic FDA data

Pure-Vu

Primary DI
05060513700014
Brand
Pure-Vu
Company
MOTUS GI MEDICAL TECHNOLOGIES LTD
Model
PV-LF-001
Catalog number
PV-LF-001
Device description
(1) Loading fixture with sealing plug
Published
2017-01-03
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
FDFColonoscope And Accessories, Flexible/Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDFColonoscope And Accessories, Flexible/RigidGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160015000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160015000Pure VuMotus GI Medical Technologies , Ltd.2016-09-22FDF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060513700014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060513700014050605137000145060513700014

GMDN Terms#

Term, Definition table
TermDefinition
Colonic lavage system, powered-flowA device assembly designed for automated or semi-automated irrigation, washing, and evacuation of debris from the colon. It typically consists of a mains electricity (AC-powered) electromechanical unit that includes a pump for infusion of non-medicated fluids (e.g., saline), an extractor (frequently using vacuum), and controls for the temperature and the rate of infusion (e.g., using a nozzle) and withdrawal of the liquid; the system is coupled to dedicated handpieces and/or to disposable catheters introduced through the rectum. It is intended to be used by a healthcare provider in a clinical setting to remove damaged tissue and/or debris (e.g., faeces, foreign objects).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure0 KiloPascal81 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius30 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-438-9996customer@motusgi.com

Regulatory Flags#

DUNS number
532775983
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060513700045Pure-VuPV-OSK-001PV-OSK-0012017-01-03
05060513700069Pure-VuPV-WSCK-001PV-WSCK-0012017-01-03
05060513700106Pure-VuPV-SLMK-001PV-SLMK-0012018-03-26
05060513700397Pure-Vu EVS GASTRO KIT 5 PackPV-GST-04-1PV-GST-04-12023-11-02
05060513700403Pure-Vu EVS GASTRO KIT, Single PackPV-GST-04-0PV-GST-04-02023-11-02
05060513700410Pure-Vu EVS COLON KIT, 5 PackPV-COL-04-1PV-COL-04-12023-11-02
05060513700427Pure-Vu EVS Colon Kit, Single PackPV-COL-04-0PV-COL-04-02023-11-02
05060513700144Pure-Vu EVS System DisposablePV-COL-03-1PV-COL-03-12023-09-06
05060513700151Pure-Vu EVS SystemPV-WSC-03-0PV-WSC-03-02023-09-06
05060513700168MOTUS GI Endoscopy Cart (Accessory)EN-CRT-03-0EN-CRT-03-02023-09-06
05060513700199Pure-Vu EVS Waste Bag (Accessory)PV-WST-03-1PV-WST-03-12023-09-06
05060513700007Pure-VuPV-WS-001PV-WS-0012017-01-03
05060513700021Pure-VuPV-UF-001PV-UF-0012017-01-03
05060513700038Pure-VuPV-LUFK-001PV-LUFK-0012017-01-03
05060513700052Pure-VuPV-OS-001PV-OS-0012017-01-03
05060513700076Pure-VuPV-WSC-001PV-WSC-0012017-01-03
05060513700120Pure-VuPV-SLM-001PV-SLM-0012018-03-26
05060513700090Pure-VuPV-OSK-001PV-OSK-0012017-01-03
05060513700083Pure-VuPV-WSCK-001PV-WSCK-0012017-01-03
05060513700113Pure-VuPV-SLMK-001PV-SLMK-0012018-03-26

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