Minuteful for Wound

Primary DI
17290017272709
Brand
Minuteful for Wound
Company
HEALTHY.IO LTD
Model
MNT WND.EN.GEN
Device description
The Minuteful for Wound device is intended to provide healthcare professionals with a tool to document, track, and monitor chronic wounds which will aid in wound care management.
Published
2022-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
FXNTape, Camera, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXNTape, Camera, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290017272709PrimaryGS10
07290017272504Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001727270917290017272709
07290017272504072900172725047290017272504

GMDN Terms#

Term, Definition table
TermDefinition
Wound management image-analysis softwareAn application software program intended to facilitate monitoring and management of a wound during the healing process based primarily on digital images of the wound. When installed on a device with a camera (e.g., hyperspectral imaging camera, smartphone), the software enables image analysis, clinical data collection and sharing, and might assist in assessing wounded tissue viability to support clinical decision making. It may incorporate artificial intelligence (AI)/deep learning algorithms.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius27 Degrees Celsius

Regulatory Flags#

DUNS number
600437232
Device count
25
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17290017272716Minuteful for WoundMNT WND.EN.GN22024-03-01
17290017272877Minuteful for Wound at HomeWND PNT.EN.GEN2024-03-01
17290017272556SPOTSPOT.EN.G252022-01-17
17290017272501SPOTSPOT.EN.GEN2020-08-25
17290017272471Minuteful - kidney testMNT KDN.US.GEN2022-11-01
07290017272504SPOTSPOT.EN.G252022-01-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B376KB1000SnapshotGLOKent Imaging IncFXN2025-07-10
00860475000383Automated Wound MeasurementsEPIC SYSTEMS CORPORATIONFXN2025-02-03
09420071400010SilhouetteStarARANZ MEDICAL LIMITEDFXN2024-04-03
17290017272716Minuteful for WoundHEALTHY.IO LTDFXN2024-03-01
17290017272877Minuteful for Wound at HomeHEALTHY.IO LTDFXN2024-03-01
00860003459850eKare inSightE-Kare Inc.FXN2022-12-01
17290017272556SPOTHEALTHY.IO LTDFXN2022-01-17
07290017272504SPOTHEALTHY.IO LTDFXN2022-01-17
00628110259325MolecuLight i:X SystemMolecuLight IncFXN2022-01-04
00627987231144Swift VisionSwift Medical IncFXN2021-03-15
17290017272501SPOTHEALTHY.IO LTDFXN2020-08-25
00627987231090Swift Skin and Wound Swift Medical IncFXN2019-10-04
00627987231106PointClickCare Skin and WoundSwift Medical IncFXN2019-10-04
00627987231113Healogics Photo+Swift Medical IncFXN2019-10-04
00627987231137Medline NE1® WMSSwift Medical IncFXN2019-10-04
00850677007143PACS Scan MobileHYLAND LLCFXN2019-08-30
06953825902605Dr.meter®Shenzhen Urion Technology Co., LtdFXN2017-03-29