FDA.reportPublic FDA data

VT1

Primary DI
03760253450157
Brand
VT1
Company
FIM MEDICAL
Model
Software
Published
2017-10-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HOXChart, Visual Acuity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOXChart, Visual AcuityOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760253450157PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760253450157037602534501573760253450157

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary function analysis system, adultA device used to measure the function of the respiratory system in adults and compliant children. It usually includes a spirometer with volume-sensing (e.g., rolling-seal, bellow) and flow-sensing (e.g., pneumotachometer) devices, a gas analyser for evaluation of absolute lung volumes and gas-diffusing capacity of the lungs, and computer capabilities for data processing and recording; a total-body plethysmograph to measure both lung volumes and airway resistance may be included. The device is mostly used for outpatient or presurgical screening, and may also be used in the diagnosis and evaluation of common diseases in older children [e.g., asthma, cystic fibrosis (CF), chest deformities].

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+33(0)672559096joanna.corre@depisteo.com
+1(619)272-1323olivier.derei@depisteo.com

Regulatory Flags#

DUNS number
577219207
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760253450638ErgofilterSP12023-09-04
03760253450645ErgofilterSP1M2023-09-04
03760253450614SPIROWINExpert2023-07-05
03760253450621SPIROWIN EXPERT DEPISTEO2023-07-05
03760253450263PipettePipette2017-09-15
03760253450577VT1Software 2022-06-07
03760253450249VT1ESSENTIAL EDITION2017-10-16
03760253450607SPIROWIN EXPERT DEPISTEO2022-03-16
03760253450010Spirowin Expert2017-05-04
03760253450447VT1 Junior SHVT1 Junior SH FF10852021-11-30
03760253450454VT1 US FAAVT1 FAA FF10842021-11-30
03760253450461Face cover for Visiolite/VT1FF10862021-11-30
03760253450522Q13 DEPISTEO SpirolyserFF1153 Q13 Depisteo2021-11-30
03760253450546VT1 DMV-BDMV-B2021-11-30
03760253450553VT1 DMV-CDMV-C2021-11-30
03760253450560VT1 DMV-DDMV-D2021-11-30
03760253450195QFLOWQFLOW2017-05-04
03760253450003SpirolyserQ132017-05-04
03760253450270NOSE CLIPNOSE CLIP2017-10-15
03760253450287TRAPPERTRAPPER2017-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971922133319YEASNChongqing Yeasn Science & Technology Co.,Ltd.HOX2026-05-01
B43050085700GoCheck KidsGobiquity, Inc.HOX2026-01-09
04987669204610Open-field Refraction SystemNIDEK CO.,LTD.HOX2026-01-08
04987669204917Open-field Refraction SystemNIDEK CO.,LTD.HOX2026-01-08
04560126269287MIRROR CHART MC-5S for COMPU VISION CV-5000TOPCON CORPORATIONHOX2025-12-09
08800019601074Visual Acuity Chart System HDC-100Huvitz Co., Ltd.HOX2025-11-19
B43071000030GoCheck MultiScreenerGobiquity, Inc.HOX2025-11-19
B43050085610GoCheck KidsGobiquity, Inc.HOX2025-11-04
B43050085600GoCheck KidsGobiquity, Inc.HOX2025-10-22
04540008310580RexxamREXXAM CO., LTD.HOX2025-10-17
04540008310610RexxamREXXAM CO., LTD.HOX2025-10-17
00812559012003NearBrightREICHERT, INC.HOX2025-08-12
00812559012010NearBrightREICHERT, INC.HOX2025-08-12
00812559012201ClearChart4REICHERT, INC.HOX2025-08-12
00812559012225ClearChart4XREICHERT, INC.HOX2025-08-12
00812559012232ClearChart4PREICHERT, INC.HOX2025-08-12
B43050085500GoCheck KidsGobiquity, Inc.HOX2025-03-20
08034028770562TOPCONVISIA IMAGING SRLHOX2025-02-20
B43071000020GoCheck MultiScreenerGobiquity, Inc.HOX2024-09-23
06971922133234YEASNChongqing Yeasn Science & Technology Co.,Ltd.HOX2024-08-08
B43050085440GoCheck KidsGobiquity, Inc.HOX2024-07-26
B43071000010GoCheck KidsGobiquity, Inc.HOX2024-07-26
08800074500008Visual Chart SystemVIEW-M TECHNOLOGY CO., LTD.HOX2024-03-25
08800074500015Visual Chart SystemVIEW-M TECHNOLOGY CO., LTD.HOX2024-03-25
08800074500022Visual Chart SystemVIEW-M TECHNOLOGY CO., LTD.HOX2024-03-25
08800074500039Visual Chart SystemVIEW-M TECHNOLOGY CO., LTD.HOX2024-03-25
08800074500114Visual Chart SystemVIEW-M TECHNOLOGY CO., LTD.HOX2024-03-25
08800074500190Self Vision TesterVIEW-M TECHNOLOGY CO., LTD.HOX2024-03-25
08800074500213Self Vision TesterVIEW-M TECHNOLOGY CO., LTD.HOX2024-03-25
08800074500282Visual Chart SystemVIEW-M TECHNOLOGY CO., LTD.HOX2024-03-25