FDA.reportPublic FDA data

ReliOn BP300 Upper Arm Blood Pressure Monitor

Primary DI
10605388044263
Brand
ReliOn BP300 Upper Arm Blood Pressure Monitor
Company
WAL-MART STORES, INC.
Model
7400RELN
Published
2017-02-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133383000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133383000HEM-7320Omron Healthcare, Inc.2014-03-04DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10605388044263PackageGS16In Commercial Distribution
00605388044266PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060538804426310605388044263
00605388044266006053880442666053880442660605388044266

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
Handling Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Handling Environment Temperature50 Degrees Fahrenheit104 Degrees Fahrenheit
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius
Storage Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-855-776-0662XX@XX.XX

Regulatory Flags#

DUNS number
051957769
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00194346726707equate1943467267072026-09-30
00194346726714equate1943467267142026-09-30
08859922800036Equate2.5cm*9.1m2026-09-30
08859922800043Equate2.5cm*3.6m2026-09-30
08859922800050Equate2.5cm*9.1m2026-09-30
08859922800067Equate3.8cm*9.1m2026-09-30
01943461100492EquateUU-012023-09-09
06971156891849Equate4L2026-07-31
069740214114323H Medical69740214114322026-07-31
069740214114943H Medical69740214114942026-07-31
06974021419490EQUATEFRT-022026-07-31
06979191882112Nanacare69791918821122026-07-31
06979191882228Nanacare69791918822282026-07-31
06979191882242Nanacarewhite2026-07-31
06979191882273BadBuddy69791918822732026-07-31
06979191882280Nanacare69791918822802026-07-31
06979191883690EQUATEwhite2026-07-31
06979191883706EQUATEblue2026-07-31
06979191883713EQUATEwhite2026-07-31

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06953825911881N/AShenzhen Urion Technology Co., LtdDXN2026-10-13
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00850078377302iHealthiHealth Labs Inc.DXN2026-10-12
00850078377326iHealthiHealth Labs Inc.DXN2026-10-12
06953825910501arboleafShenzhen Urion Technology Co., LtdDXN2026-10-10
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