FDA.reportPublic FDA data

COMFORT TOUCH

Primary DI
00850024759404
Brand
COMFORT TOUCH
Company
Slv Pharmaceuticals LLC
Model
Blood Cuff
Device description
COMFORT TOUCH BLOOD PRESSURE CUFF - LARGE
Published
2021-05-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true

Product Codes#

Code, Name table
CodeName
DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2

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
00850024759404PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850024759404008500247594048500247594040850024759404

GMDN Terms#

Term, Definition table
TermDefinition
Walking aid handgripA device designed to help a person using a walking aid to grasp the walking aid (e.g., a walking stick, cane, crutch, walking frame or rollator) securely. Included are adjustable grips, grips with antislip material and grips of special material such as foam. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081225162
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00373317624512AUMSAFETY PEN NEEDLES 32G -4MM2022-03-08
00373317628442AUMMINI PEN NEEDLES 31G - 4MM2022-03-08
00373317628459AUMMINI PEN NEEDLES 31G - 5MM2022-03-08
00373317628466AUMMINI PEN NEEDLES 31G - 6MM2022-03-08
00373317628480AUMMINI PEN NEEDLES 31G - 8MM2022-03-08
00373317628541AUMMINI PEN NEEDLES 32G - 4MM2022-03-08
00373317628558AUMMINI PEN NEEDLES 32G - 5MM2022-03-08
00373317628565AUMMINI PEN NEEDLES 32G - 6MM2022-03-08
00373317628589AUMMINI PEN NEEDLES 32G - 8MM2022-03-08
00373317628640AUMMINI PEN NEEDLES 33G - 4MM2022-03-08
00373317628657AUMMINI PEN NEEDLES 33G - 5MM2022-03-08
00373317628664AUMMINI PEN NEEDLES 33G - 6MM2022-03-08
00373317464712BREATH COMFORTHUMIDIFIER2022-03-08
00373317495211BREATHE COMFORT OPTICHAMBERS2022-03-08
00373317495228BREATHE COMFORT OPTICHAMBERS2022-03-08
00373317568212AUMMOISTURIZING GEL SOCKS 2022-03-08
00373317000064AUMSAFETY PEN NEEDLES 32G -4MM2022-03-08
00373317000033AUMMINI PEN NEEDLES 31G - 4MM2022-03-08
00373317000026AUMMINI PEN NEEDLES 31G - 5MM2022-03-08
00373317000057AUMMINI PEN NEEDLES 31G - 6MM2022-03-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00093764604737A&D MedicalA&D COMPANY, LIMITEDDXN2026-09-25
00093764604744A&D MedicalA&D COMPANY, LIMITEDDXN2026-09-25
06953825911874AlphaMedShenzhen Urion Technology Co., LtdDXN2026-09-22
06953825911850sakerplusShenzhen Urion Technology Co., LtdDXN2026-09-18
06920485308580P PANACAREShenzhen BSX Technology Electronics Co., Ltd.DXN2026-08-26
06944413835153Telemetry MonitorEdan Instruments, Inc.DXN2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.DXN2026-08-26
00634782102265Advantage™AMERICAN DIAGNOSTIC CORPDXN2026-08-25
00810226442306ViveVIVE HEALTH LLCDXN2026-08-25
00856324008778PARAMEDSILEX GLOBAL LLCDXN2026-08-22
06971522821753LineshareShenzhen Finicare Co., LtdDXN2026-08-22
06971522821760LineshareShenzhen Finicare Co., LtdDXN2026-08-22
06953825911805FOCUSED ADULT ADHD CLINICShenzhen Urion Technology Co., LtdDXN2026-08-19
09120073932778CNAP® ArmslingCNSystems Medizintechnik GmbHDXN2026-08-18
09120073932785CNAP® double finger cuff "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932792CNAP® double finger cuff "medium"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932808CNAP® double finger cuff "large"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932815CNAP® double finger cuff "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932822CNAP® double finger cuff "medium"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932839CNAP® double finger cuff "large"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932846CNAP® double finger cuff "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932853CNAP® double finger cuff "medium"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932860CNAP® double finger cuff "large"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932877CNAP® double finger cuff "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932884CNAP® double finger cuff "medium"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932891CNAP® double finger cuff "large"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073933034CNAP® Armsling "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073933041TFC Armsling "small"CNSystems Medizintechnik GmbHDXN2026-08-18
06953825911799SAKERShenzhen Urion Technology Co., LtdDXN2026-08-17
06920485308542BSXShenzhen BSX Technology Electronics Co., Ltd.DXN2026-08-14