FDA.reportPublic FDA data

FloShield/Air

Primary DI
10815128020017
Brand
FloShield/Air
Company
MINIMALLY INVASIVE DEVICES, INC.
Model
FSS-02-0500T
Catalog number
FSS-02-0500T
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
10815128020017PackageGS16In Commercial Distribution
00815128020010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081512802001710815128020017
00815128020010008151280200108151280200100815128020010

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776422745MillenniumAvalign Technologies, Inc.GCJ2026-08-03
00190776422752MillenniumAvalign Technologies, Inc.GCJ2026-08-03
04026704934812TELEFLEXTELEFLEX INCORPORATEDGCJ2026-08-03
B382SD4131490Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
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B382SD56325330Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56400150Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56534210Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD567910130Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56914330Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
00190776421960MillenniumAvalign Technologies, Inc.GCJ2026-07-31
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14026704921741TELEFLEXTELEFLEX INCORPORATEDGCJ2026-07-31
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B382SD13798130Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD14678780Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD15378970Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD15458990Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD161090Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD169920Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD30109760Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
00198506092183ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-29
00198506092640ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-29
00198506093562ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-29
00198506093838ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-29
B354OSRP80Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-07-29
00198506092435ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-28