FDA.reportPublic FDA data

Dr.meter®

Primary DI
06953825902605
Brand
Dr.meter®
Company
Shenzhen Urion Technology Co., Ltd
Model
U80B
Published
2017-03-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
FXNTape, Camera, Surgical

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160019000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160019000U80 Series Upper Arm Electronic Blood Pressure MonitorShenzhen Urion Technology Co., Ltd.2016-04-22DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06953825902605PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06953825902605069538259026056953825902605

GMDN Terms#

Term, Definition table
TermDefinition
Automatic-inflation electronic sphygmomanometer, portable, arm/wristAn electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm/wrist-cuff inflation and measurement cycles. It typically displays current heart rate and mean arterial pressure in addition to systolic and diastolic blood pressures; it may have memory to store blood pressure values and may sound an alarm if blood pressure exceeds pre-set limits. This device is designed to be portable (e.g., hand-held or carried in a pouch) and is often used for emergency services or home blood pressure monitoring.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
421294358
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06953825911041ELERAU82V2026-06-03
06953825911188sakerplusU90B2026-06-03
06953825911218AlphamedU90B2026-06-03
06953825911225AlphamedU90B2026-06-03
06953825911232AlphamedU16P2026-06-03
06953825911249KPMNU90BPro2026-06-03
06953825911072N/AU81Z2026-05-11
06953825911089HUMHEALTHU81CH2026-05-11
06953825911010N/AU80B2026-04-08
06953825911027N/AU82Y2026-04-08
06953825910983lyobU86Y2026-03-20
16953825910980lyobU86Y2026-03-20
06953825910969N/AU83Z2026-03-17
16953825910966N/AU83Z2026-03-17
06953825910952N/AU81X2026-03-09
16953825910959N/AU81X2026-03-09
06953825910914medisanaBU 6302026-03-03
06953825910907SDUNWU80Z2026-02-16
16953825910904SDUNWU80Z2026-02-16
06953825910846N/AU82V2026-02-06

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
17290017272709Minuteful for WoundHEALTHY.IO LTDFXN2022-09-15
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