FDA.reportPublic FDA data

FloShield/Air

Primary DI
00815128020133
Brand
FloShield/Air
Company
MINIMALLY INVASIVE DEVICES, INC.
Model
FSB-01-1000T
Catalog number
FSB-01-1000T
Device description
The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended to facilitate intra-operative defogging of the lens of a laparoscope and debris deflection during minimally-invasive surgery while maintaining visualization of the surgical site.
Published
2016-07-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery
OCTAnti Fog Solution And Accessories, Endoscopy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2
OCTAnti Fog Solution And Accessories, EndoscopyGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10815128020130PackageGS16In Commercial Distribution
00815128020133PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081512802013010815128020130
00815128020133008151280201338151280201330815128020133

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope lens cleaner, gas/fluid, single-useA sterile device intended to be used for the in situ removal of fog/blood/debris from the lens of an endoscope (e.g., laparoscope), by directing gas and/or liquid to the edge of the lens. It is typically a multichannel sleeve with connection tubing. Gases/fluids are intended to be directed from a source through the channels within the sleeve to the lens. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter10Millimeter
Outer Diameter12Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Fahrenheit115 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
1-614-340-3349inquiries@floshield.com

Regulatory Flags#

DUNS number
793517660
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815128020652Flo-XFX10FX102016-07-25
00815128020010FloShield/AirFSS-02-0500TFSS-02-0500T2016-07-25
00815128020027FloShield/AirFSB-02-0500TFSB-02-0500T2016-07-25
00815128020041FloShield/AirFSS-02-0530TFSS-02-0530T2016-07-25
00815128020119FloShield/AirFSS-03-1000TFSS-03-1000T2016-07-25
00815128020317FloShield/PlusFSS-02-0500FSS-02-05002016-12-12
00815128020409FloShield/PlusFSS-02-1000FSS-02-10002016-12-12
00815128020492FloShield/PlusFSS-04-1030FSS-04-10302016-12-12
00815128020515FloShield/PlusFSB-02-1030FSB-02-10302016-12-12
00815128020003FloShield/AirFSS-01-0500TFSS-01-0500T2016-07-25
10815128020017FloShield/AirFSS-02-0500TFSS-02-0500T2016-07-25
10815128020024FloShield/AirFSB-02-0500TFSB-02-0500T2016-07-25
00815128020034FloShield/AirFSS-01-0530TFSS-01-0530T2016-07-25
10815128020048FloShield/AirFSS-02-0530TFSS-02-0530T2016-07-25
00815128020058FloShield/AirFSB-02-0530TFSB-02-0530T2016-07-25
00815128020065FloShield/AirFSS-01-0545TFSS-01-0545T2016-07-25
00815128020072FloShield/AirFSS-02-0545TFSS-02-0545T2016-07-25
00815128020089FloShield/AirFSB-02-0545TFSB-02-0545T2016-07-25
00815128020096FloShield/AirFSS-01-1000TFSS-01-1000T2016-07-25
00815128020102FloShield/AirFSS-02-1000TFSS-02-1000T2016-07-25

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