FDA.reportPublic FDA data

E-Sphyg™ 3

Primary DI
00634782097356
Brand
E-Sphyg™ 3
Company
AMERICAN DIAGNOSTIC CORP
Model
9003BATC
Catalog number
9003BATC
Device description
Battery Comp Cover & 2 screws,E-sphyg 3
Published
2020-01-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
00634782097356PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00634782097356006347820973566347820973560634782097356

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
Storage Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-232-2670info@adctoday.com

Regulatory Flags#

DUNS number
108999095
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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Primary DI, Brand, Model table
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00634782903190Advantage™611561152025-11-24
00634782903152Advantage™611261122025-09-19
00634782903169Advantage™612161212025-09-19
00634782903176Advantage™6121SA6121SA2025-09-19
00634782903183Advantage™6121X6121X2025-09-19
00634782903091Adtemp™ 424N-40424N-402025-02-05
00634782603106Adtemp™ 424N-200424N-2002025-02-05
00634782903039Adtemp™ 424N424N2025-01-29
00634782600402Adscope®608LPST608LPST2023-01-11
00634782600600Adscope®600IMCA600IMCA2023-01-10
00634782600617Adscope®600IST600IST2023-01-10
00634782600624Adscope®601IMCA601IMCA2023-01-10
00634782600631Adscope®601IST601IST2023-01-10
00634782600648Adscope®601RGBK601RGBK2023-01-10
00634782600655Adscope®608RGBK608RGBK2023-01-10
00634782600662Adscope®608RGW608RGW2023-01-10
00634782600679Adscope®606RGBK606RGBK2023-01-10

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
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06975164324627HingmedShenzhen Hingmed Medical Instrument Co., Ltd.DXN2026-03-24
00816042016356FORAFORA CARE INC.DXN2026-03-20
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