FDA.reportPublic FDA data

A&D Medical

Primary DI
00093764604737
Brand
A&D Medical
Company
A&D COMPANY, LIMITED
Model
UA-652BLE
Catalog number
UA-652BLE
Device description
Premium Upper Arm Blood Pressure Monitor.
Published
2026-09-25
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
00093764604737PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00093764604737000937646047370937646047370093764604737

GMDN Terms#

Term, Definition table
TermDefinition
Automatic-inflation electronic sphygmomanometer, non-portableAn electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm-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 not designed to be portable and is typically used bedside.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity00
Handling Environment Temperature00
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
1-888-726-9966htn@andonline.com

Regulatory Flags#

DUNS number
691722987
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
00093764604744A&D MedicalUA-606UA-6062026-09-25
00093764604720A&D MedicalUA-1020CEL-CSUA-1020CEL-CS2026-05-08
00093764604553A&D MedicalUA-660CNUA-660CN2026-02-27
00093764604522A&D MedicalUA-810BLEUA-810BLE2025-02-19
00093764604539A&D MedicalUA-910BLEUA-910BLE2025-02-19
00093764604447A&D MedicalUA-1020CELUA-1020CEL2024-12-10
00093764604140A&D MedicalUC-356BLEUC-356BLE2024-10-18
00093764604546A&D MedicalUC-356BLE-STUC-356BLE-ST2024-10-18
00093764604454A&D MedicalUC-352CELUC-352CEL2024-10-16
00093764604492A&D MedicalUA-660UA-6602024-09-01
00093764604508A&D MedicalUA-770BLEUA-770BLE2024-09-01
00093764604515A&D MedicalUA-1040TBLEUA-1040TBLE2024-09-01
00093764604461A&D MedicalUC-450BLE-CVUC-450BLE-CV & UC-450BLE2024-01-01
00093764603501A&D MedicalTM-2657PTM-2657P, TM-2657P-RS, TM-2657P-BT2016-09-23
00093764604133A&D MedicalUP-200UP-2002024-02-15
00093764600623A&D MedicalUA-789UA-789AC2016-09-23
00093764601576A&D MedicalUA-705UA-705V2016-09-23
00093764601583A&D MedicalUA-705UA-705VL2016-09-23
00093764602870A&D MedicalUA-1020UA-10202016-09-23
00093764602931A&D MedicalUA-1030TUA-1030T2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06953825911942CofoeShenzhen Urion Technology Co., LtdDXN2026-10-20
06953825911928CofoeShenzhen Urion Technology Co., LtdDXN2026-10-19
06953825911904saidianShenzhen Urion Technology Co., LtdDXN2026-10-14
06974560230655ziqingShenzhen Ziqing Medical Equipment Co.,Ltd.DXN2026-10-14
06953825911881N/AShenzhen Urion Technology Co., LtdDXN2026-10-13
06974560230648ziqingShenzhen Ziqing Medical Equipment Co.,Ltd.DXN2026-10-13
00850078377302iHealthiHealth Labs Inc.DXN2026-10-12
00850078377326iHealthiHealth Labs Inc.DXN2026-10-12
06953825910501arboleafShenzhen Urion Technology Co., LtdDXN2026-10-10
06933257920187Electronic Blood Pressure MonitorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.DXN2026-10-09
06933257926066YUWELL Electronic Blood Pressure MonitorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.DXN2026-10-09
06933257931688YUWELL Electronic Blood Pressure MonitorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.DXN2026-10-09
06933257947016YUWELL Electronic Blood Pressure MonitorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.DXN2026-10-09
06933257947023Electronic Blood Pressure MonitorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.DXN2026-10-09
06933257947030YUWELL Electronic Blood Pressure MonitorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.DXN2026-10-09
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06973826012295AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
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06973826012318AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
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06973826012363AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012370AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012387AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09