FDA.reportPublic FDA data

AccuVein

Primary DI
00850019808070
Brand
AccuVein
Company
Accuvein Inc.
Model
HF580
Device description
Powered, Goose Neck Hands-Free Wheeled Stand
Published
2022-02-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00850019808070PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850019808070008500198080708500198080700850019808070

GMDN Terms#

Term, Definition table
TermDefinition
Mobile medical equipment stand, non-poweredA non-powered (non-active) mobile device (on wheels) designed to support medical equipment used for clinical purposes [e.g., in an operating room and/or an examination/treatment room]. It may include manually-adjustable articulated arms to enable dynamic positioning of equipment; the equipment to be supported is not included. The device does not include a battery pack but might include a battery holder and electrical connection wiring to feed power to medical equipment.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
807920546
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850019808018AccuVeinAV5002021-03-12
00850019808049AccuVeinHF5102021-08-25
00850019808025AccuVeinHF5702021-03-12
00850019808032AccuVeinHF5502021-03-12

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
M870134002102021VeinViewer 3.0 FlexChristie Medical Holdings, Inc.KZA2022-09-14
00850019808049AccuVeinAccuvein Inc.KZA2021-08-25
00850019808018AccuVeinAccuvein Inc.KZA2021-03-12
00850019808025AccuVeinAccuvein Inc.KZA2021-03-12
00850019808032AccuVeinAccuvein Inc.KZA2021-03-12
00855784004009VeinsiteSpirometricsKZA2018-12-04