FDA.reportPublic FDA data

Pure-Vu

Primary DI
05060513700083
Brand
Pure-Vu
Company
MOTUS GI MEDICAL TECHNOLOGIES LTD
Model
PV-WSCK-001
Catalog number
PV-WSCK-001
Device description
(1) Workstation connector
Published
2017-01-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
05060513700083PackageGS15In Commercial Distribution
05060513700069PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060513700083050605137000835060513700083
05060513700069050605137000695060513700069

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
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
true
Expiration date on label
true
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
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
05060513700014Pure-VuPV-LF-001PV-LF-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
05060513700113Pure-VuPV-SLMK-001PV-SLMK-0012018-03-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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