FDA.reportPublic FDA data

AC Adapter for HEM-907XL

Primary DI
00073796149079
Brand
AC Adapter for HEM-907XL
Company
Omron Healthcare, Inc.
Model
HEM-ADPT907
Catalog number
HEM-ADPT907
Device description
AC Adapter for HEM-907XL, Digital Blood Pressure Monitor
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
K032305000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032305000OMRON INTELLISENSE DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-907XLOmron Healthcare, Inc.2004-02-11DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10073796149076PackageGS120In Commercial Distribution
20073796149073PackageGS12In Commercial Distribution
00073796149079PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1007379614907610073796149076
2007379614907320073796149073
00073796149079000737961490790737961490790073796149079

GMDN Terms#

Term, Definition table
TermDefinition
Basic power supplyA device designed to receive alternating-current energy (AC-power) from a mains electricity power line and deliver one or more regulated direct-current outputs to supply devices with electrical energy. It typically consists of a step-up or step-down transformer, a rectifier, a filter, and an electronic regulator that keeps the voltage, current, or power output stable over a broad range of loads and input voltages.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Handling Environment Temperature50 Degrees Fahrenheit104 Degrees Fahrenheit
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
1-800-634-4350ohiquality@omron.com

Regulatory Flags#

DUNS number
054318779
Device count
1
Lot or batch
true

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