FDA.reportPublic FDA data

Venturi MicroDryer

Primary DI
00860002853185
Brand
Venturi MicroDryer
Company
GI Scientific LLC
Model
GI-VDTUBING-005-32
Device description
Filtered Air Tubing Set
Published
2024-04-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNLAccessories, Cleaning Brushes, For Endoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNLAccessories, Cleaning Brushes, For EndoscopeGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860002853178PrimaryGS10
00860002853185Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860002853178008600028531788600028531780860002853178
00860002853185008600028531858600028531850860002853185

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument/endoscope cleaning utensil, single-useA non-absorbent, non-powered, hand-held device in the form of a brush, a wire, strip of metal, or handle intended to clean the exterior and/or interior (lumen) of a surgical instrument (e.g., bur, reamer, bone tap, suturing device, sheath/shaft, ultrasonic surgical handpiece) and/or endoscope. The bristles, fibres or spines of brushes may be mounted along a single plane or radiate out around a central shaft, and may be soft or stiff; the shaft/handle of brushes may be flexible or rigid. The device may be used to clean endoscopic or open-surgery instruments, and it may have a handle or a connector/adaptor at the proximal end. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
703-289-0495support@giscientific.com

Regulatory Flags#

DUNS number
075723383
Device count
32
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
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
00850075039005Venturi DryGI-PVDL-001-12026-02-10
00850075039036Venturi DryGI-FVDM-002-12026-02-10
00850075039050Venturi DryGI-PVDM-002-12026-02-10
00850075039074Venturi DryGI-OVDS-003-12026-02-10
00850075039098Venturi DryGI-FVDS-003-12026-02-10
00850075039111Venturi DryGI-PVDS-003-12026-02-10
00850075039128Venturi DryGI-OVDXS-004-12026-02-10
00850075039159Venturi DryGI-PVDXS-004-12026-02-10
00850075039197Venturi CleanGI-VCS-003-12026-02-10
00850075039210Venturi CleanGI-VCXS-004-12026-02-10
00860002853109Venturi CleanGI-VCL-001-12026-02-10
00860007020902Venturi CleanGI-VCM-002-12026-02-10
00860007020940Venturi CleanGI-VOR-001-12026-02-10
00860007020964Venturi DryGI-OVDM-002-12026-02-10
10850075039002Venturi DryGI-PVDL-001-12026-02-10
10850075039033Venturi DryGI-FVDM-002-12026-02-10
10850075039057Venturi DryGI-PVDM-002-12026-02-10
10850075039071Venturi DryGI-OVDS-003-12026-02-10
10850075039095Venturi DryGI-FVDS-003-12026-02-10
10850075039118Venturi DryGI-PVDS-003-12026-02-10

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