FDA.reportPublic FDA data

FloShield/Air

Primary DI
10815128020048
Brand
FloShield/Air
Company
MINIMALLY INVASIVE DEVICES, INC.
Model
FSS-02-0530T
Catalog number
FSS-02-0530T
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
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10815128020048PackageGS16In Commercial Distribution
00815128020041PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081512802004810815128020048
00815128020041008151280200418151280200410815128020041

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 Diameter5Millimeter

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
793517660
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
00815128020133FloShield/AirFSB-01-1000TFSB-01-1000T2016-07-25
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812231033906PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
00812231033913PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
00812231033920PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
00812231034095PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
00812231034101PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
04717480900336Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900343Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900350Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900367Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900398Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900404Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900763Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900770Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900787Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900800Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
E496C05HPDH0Handle for pneumodissection HookAB MEDICAGCJ2026-06-08
E496C05IDCH20ST1Hook insert and tube for pneumodissection D=5,0mm Lg=20cm, sterile single useAB MEDICAGCJ2026-06-08
E496C05IDCH33ST1Hook insert and tube for pneumodissection D=5,0mm Lg=33cm, sterile single useAB MEDICAGCJ2026-06-08
E496C35IDCH20ST1Hook insert and tube for pneumodissection D=3,5mm Lg=20cm, sterile single useAB MEDICAGCJ2026-06-08
E496C35IDCH33ST1Hook insert and tube for pneumodissection D=3,5mm Lg=33cm, sterile single useAB MEDICAGCJ2026-06-08
00198506091414ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-05
00198506091421ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-05
00198506091438ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-05
00198506091247ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-03
00198506091254ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-03
00192896123427TrocarSONTEC INSTRUMENTS, INC.GCJ2026-06-02
00192896123434Flexible Trocar SleeveSONTEC INSTRUMENTS, INC.GCJ2026-06-02
E496C35BTU200C35-Bipolar Tube L 20cm D 3,5mmAB MEDICAGCJ2026-05-28
E496C35IBDM200C35- Bipolar Maryland Insert L20cm D 3,5mmAB MEDICAGCJ2026-05-28
E496C35IBFS200C35-Bipolar Insert L 20cm D 3,5mmAB MEDICAGCJ2026-05-28