FDA.reportPublic FDA data

NaviAid™ SPARK

Primary DI
07290018671528
Brand
NaviAid™ SPARK
Company
SMART MEDICAL SYSTEMS LTD
Model
SPARK
Catalog number
28-016
Device description
An inflation system providing controlled inflation and deflation of the NaviAid™ AB balloon.
Published
2020-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ODCEndoscope Channel Accessory

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODCEndoscope Channel AccessoryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112106000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112106000NAVIAID ICVI-F,S,B,R DEVICESmart Medical Systems , Ltd.2012-02-06ODC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290018671528PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290018671528072900186715287290018671528

GMDN Terms#

Term, Definition table
TermDefinition
Catheter/overtube balloon inflator, reusableA device designed to inflate and regulate the pressure of the balloon of a catheter, endoscopic overtube, or other invasive device (e.g., tamp, endomicroscopy probe), typically by injecting and aspirating fluid or air within the balloon, and to deflate the balloon during a medical procedure. It typically consists of a dedicated manual syringe/plunger or electronic mechanism for inflation/deflation, an analogue or digital gauge/screen for monitoring pressure, a locking mechanism, and a connecting tube. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure0.7 millibar1.1 millibar
Handling Environment Humidity30 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure0.7 millibar1.1 millibar
Storage Environment Humidity0 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+97297444321info@smartmedsys.com

Regulatory Flags#

DUNS number
649905544
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290018671658NaviAid™ ABCABC23-0102024-01-14
17290018671662NaviAid™ ABCABC23-0102024-01-14
07290018671214G-EYE ColonoscopeG-EYEHQ190L40-5602023-07-18
07290018671221G-EYE ColonoscopeG-EYEHQ190I40-5602023-07-18
07290018671238G-EYE ColonoscopeG-EYEH190L40-5602023-07-18
07290018671245G-EYE ColonoscopeG-EYEH190I40-5602023-07-18
07290018671252G-EYE ColonoscopeG-EYEQ180AL40-5602023-07-18
07290018671269G-EYE ColonoscopeG-EYEQ180AI40-5602023-07-18
07290018671276G-EYE ColonoscopeG-EYEH180AL40-5602023-07-18
07290018671283G-EYE ColonoscopeG-EYEH180AI40-5602023-07-18
07290018671009G-EYE ColonoscopeG-EYE760R-V/L40-5962020-12-02
07290018671016G-EYE ColonoscopeG-EYE760ZP-V/L40-5962020-12-02
07290018671023G-EYE ColonoscopeG-EYE760P-V/L40-5962020-12-02
07290018671030G-EYE ColonoscopeG-EYE760S-V/L40-5962020-12-02
07290018671047G-EYE ColonoscopeG-EYE760Z-V/L40-5962020-12-02
07290018671504NaviAid™ SPARKCSPARKC40-0162020-12-02
07290018671634NaviAid™ ABAB-R31-0102020-12-02
07290018671054G-EYE ColonoscopeG-EYEHQ190L40-5502020-12-01
07290018671061G-EYE ColonoscopeG-EYEHQ190I40-5502020-12-01
07290018671078G-EYE ColonoscopeG-EYEH190L40-5502020-12-01

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