FDA.reportPublic FDA data

Medline

Primary DI
00193489038654
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
MDS7001B
Catalog number
MDS7001B
Device description
BLUETOOTH AUTOMATIC, ARM, BP MONITOR
Published
2022-08-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00193489038654PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00193489038654001934890386541934890386540193489038654

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry. Keep away from sunlight. Avoid excessive heat
Storage Environment Humidity093 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850047516046Clovis AI RPMRemote Smart Health, LLCDXN2026-05-26
10850047516043Clovis AI RPMRemote Smart Health, LLCDXN2026-05-26
06920485308412PANACAREShenzhen BSX Technology Electronics Co., Ltd.DXN2026-05-23
16942284601461SEJOYJOYTECH HEALTHCARE CO.,LTDDXN2026-03-24
26942284601482SEJOYJOYTECH HEALTHCARE CO.,LTDDXN2026-03-24
26942284601499SEJOYJOYTECH HEALTHCARE CO.,LTDDXN2026-03-24
26942284601505SEJOYJOYTECH HEALTHCARE CO.,LTDDXN2026-03-24
26942284601512SEJOYJOYTECH HEALTHCARE CO.,LTDDXN2026-03-24
26942284601529SEJOYJOYTECH HEALTHCARE CO.,LTDDXN2026-03-24
26942284601864SEJOYJOYTECH HEALTHCARE CO.,LTDDXN2026-03-24
16942284601874SEJOYJOYTECH HEALTHCARE CO.,LTDDXN2026-03-24
16942284601881SEJOYJOYTECH HEALTHCARE CO.,LTDDXN2026-03-24
26942284601895SEJOYJOYTECH HEALTHCARE CO.,LTDDXN2026-03-24
16942284601904SEJOYJOYTECH HEALTHCARE CO.,LTDDXN2026-03-24
26942284601987SEJOYJOYTECH HEALTHCARE CO.,LTDDXN2026-03-24
06951727602906MBUPAIShenzhen Changkun Technology Co., Ltd.DXN2026-03-24
26970392218445SEJOYJOYTECH HEALTHCARE CO.,LTDDXN2026-03-24
06975164324436HingmedShenzhen Hingmed Medical Instrument Co., Ltd.DXN2026-03-24
06975164324535HingmedShenzhen Hingmed Medical Instrument Co., Ltd.DXN2026-03-24
06975164324542HingmedShenzhen Hingmed Medical Instrument Co., Ltd.DXN2026-03-24
06975164324610HingmedShenzhen Hingmed Medical Instrument Co., Ltd.DXN2026-03-24
06975164324627HingmedShenzhen Hingmed Medical Instrument Co., Ltd.DXN2026-03-24
00816042016356FORAFORA CARE INC.DXN2026-03-20
06953205995074Arm Type Automatic Blood Pressure MonitorShenzhen Jiacom Technology Co., LtdDXN2026-03-20
06953205995081Arm Type Automatic Blood Pressure MonitorShenzhen Jiacom Technology Co., LtdDXN2026-03-20
06953205995098Arm Type Automatic Blood Pressure MonitorShenzhen Jiacom Technology Co., LtdDXN2026-03-20
06953205995104Arm Type Automatic Blood Pressure MonitorShenzhen Jiacom Technology Co., LtdDXN2026-03-20
06953205995111Arm Type Automatic Blood Pressure MonitorShenzhen Jiacom Technology Co., LtdDXN2026-03-20
06953205995128Arm Type Automatic Blood Pressure MonitorShenzhen Jiacom Technology Co., LtdDXN2026-03-20
06953205995135Arm Type Automatic Blood Pressure MonitorShenzhen Jiacom Technology Co., LtdDXN2026-03-20