FDA.reportPublic FDA data

TabletVu

Primary DI
00865351000389
Brand
TabletVu
Company
INTRAVU, INC.
Model
IV-ASY-2000
Catalog number
IV-ASY-2000
Device description
TabletVu is a reusable visualization system for use with the IntraVu Scope.
Published
2021-10-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery
HRXArthroscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2
HRXArthroscopeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181982000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181982000MIDAScope and Introducer Kit, and MIDASystemIntravu, Inc.2018-08-21HRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00865351000389PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00865351000389008653510003898653510003890865351000389

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic video image display monitorA mains electricity (AC-powered) visual display unit (VDU), commonly known as a screen or a monitor, designed to be used exclusively in conjunction with a flexible video endoscope to display to the operator the graphical information captured by the endoscope to facilitate its manipulation during the endoscopic procedure; typically difficult and non-difficult intubation procedures to maintain an open airway. It is typically a portable device with a liquid crystal display (LCD) colour screen and a direct electronic signal connection to the endoscope.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure55 KiloPascal101 KiloPascal
Handling Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-18 Degrees Celsius60 Degrees Celsius
Storage Environment Atmospheric Pressure55 KiloPascal101 KiloPascal
Storage Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-18 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18774977705ProductInfo@IntraVu.com

Regulatory Flags#

DUNS number
116708692
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
0085002390503130 SideVu-60IV-ASY-3060IV-ASY-30602023-07-03
0085002390504830 SideVu-90IV-ASY-3090IV-ASY-30902023-07-03
0085002390505530 SideVu-120IV-ASY-3120IV-ASY-31202023-07-03
00850023905000AccessVu 90IV-ASY-1609IV-ASY-16092021-10-15
00850023905017AccessVu 60IV-ASY-1606IV-ASY-16062021-10-15
00850023905024AccessVu 120IV-ASY-1612IV-ASY-16122021-10-15
00865351000341IntraVu Scope 120IV-ASY-1120IV-ASY-11202019-12-02
00865351000358IntraVu Scope 90IV-ASY-1090IV-ASY-10902019-12-02
00865351000365IntraVu Scope 60IV-ASY-1060IV-ASY-10602019-12-02
00865351000303MIDAScope™ - 120 and Introducer KitIV-ASY-0600IV-ASY-06002019-01-18
00865351000327MIDAScope™ - 90 and Introducer KitIV-ASY-0700IV-ASY-07002019-01-18
00865351000334MIDAScope™ - 60 and Introducer KitIV-ASY-0800IV-ASY-08002019-01-18
00865351000372IntraVu TabletIV-ASY-1000IV-ASY-10002019-12-02
00865351000310MIDASystem™ IV-ASY-0450IV-ASY-04502019-01-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776435295MillenniumAvalign Technologies, Inc.GCJ2026-10-19
00190776435455MillenniumAvalign Technologies, Inc.GCJ2026-10-19
04250337121015Combo Optic AdapterJoimax GmbHHRX2026-10-19
08058964729767Easy Winch 13 G, 15 mmG21 SRLHRX2026-10-19
08058964729774Easy Winch 13 G, 10 mmG21 SRLHRX2026-10-19
B354OSCVORTH80Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH81Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH82Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH83Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH84Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH85Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH89Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
04548736175013OLYMPUSSONY CORPORATIONGCJ2026-10-15
04548736175068OLYMPUSSONY CORPORATIONGCJ2026-10-15
04548736175112OLYMPUSSONY CORPORATIONGCJ2026-10-15
00190776434922MillenniumAvalign Technologies, Inc.GCJ2026-10-14
00190776434823MillenniumAvalign Technologies, Inc.GCJ2026-10-13
00190776434854MillenniumAvalign Technologies, Inc.GCJ2026-10-13
B382SD56300680Surgical DirectSurgical Direct, Inc.GCJ2026-10-13
B382SD563006820Surgical DirectSurgical Direct, Inc.GCJ2026-10-13
00190776434250MillenniumAvalign Technologies, Inc.GCJ2026-10-09
00848657078481AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GCJ2026-10-08
00848657078498AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GCJ2026-10-08
00190776433697MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433703MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433710MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433727MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433338MillenniumAvalign Technologies, Inc.GCJ2026-10-05
00190776433345MillenniumAvalign Technologies, Inc.GCJ2026-10-05
00190776433031MillenniumAvalign Technologies, Inc.GCJ2026-10-01