VeinViewer 3.0 Flex

Primary DI
M870134002102021
Brand
VeinViewer 3.0 Flex
Company
Christie Medical Holdings, Inc.
Model
3.0 Flex
Catalog number
134-002102-02
Device description
VeinViewer Flex is designed for ease of use. VeinViewer Flex utilizes visible and near-infrared light for vascular imaging to illuminate and project the subcutaneous venous structure directly onto a patient’s skin. AVIN™ (Active Vascular Imaging Navigation) allows the user to assess multiple access points with a re al-time digitalimage .
Published
2022-09-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KZADevice, Vein Location, Liquid Crystal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KZADevice, Vein Location, Liquid CrystalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M870134002102021PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held multi-spectral vascular imaging deviceA battery-powered, hand-held device designed to utilize visible and near infrared (IR) light for superficial vascular structure imaging by illuminating and projecting the subcutaneous venous structure of a patient onto the patient's skin surface. The device includes controls and an optical unit for non-laser imaging which allows the operator to assess multiple vascular access points with a real-time digital image [active vascular imaging navigation (AVIN)] on any part of the anatomy. The device includes rechargeable batteries that allow its operation for a limited period. It is used in a variety of clinical settings. This portable device can also be attached to static mounting arm.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-10 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117398857
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M870134003104011VeinViewer 4.0 Vision24.0 Vision2134-003104-012022-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04711099370009Meerkat Vein Finder modelOPCOM INC.KZA2024-12-20
06926802602805Vein IlluminatorMEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.KZA2024-02-05
06926802602812Vein IlluminatorMEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.KZA2024-02-05
00860010285800NextVeinNextvein LLCKZA2023-06-06
26975913450014AHT INCAHT INCKZA2023-05-31
06971141530227VEINCASShenzhen Vivolight Medical Device & Technology Co., Ltd.KZA2023-04-20
M870134003104011VeinViewer 4.0 Vision2Christie Medical Holdings, Inc.KZA2022-09-14
00850019808070AccuVeinAccuvein Inc.KZA2022-02-10
00850019808049AccuVeinAccuvein Inc.KZA2021-08-25
00850019808018AccuVeinAccuvein Inc.KZA2021-03-12
00850019808025AccuVeinAccuvein Inc.KZA2021-03-12
00850019808032AccuVeinAccuvein Inc.KZA2021-03-12
00855784004009VeinsiteSpirometricsKZA2018-12-04