FDA.reportPublic FDA data

Luer lock connector set for HEM-907

Primary DI
00073796907358
Brand
Luer lock connector set for HEM-907
Company
Omron Healthcare, Inc.
Model
907Connector
Published
2016-09-16
Public version status
Update
Distribution status
Not 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
00073796907358PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00073796907358000737969073580737969073580073796907358

GMDN Terms#

Term, Definition table
TermDefinition
Low-pressure tubing connector, reusableA device designed to connect together two or more tubes typically with the intention of creating an extension. The connecting ends of this device will typically be serrated to provide a secure grip for the applied tubes. Clips or other forms of locking devices may be applied over the tubes to further secure the fitting. This device will not be appropriate for connecting tubes that are designed to carry (withstand) high pressures [e.g., high pressure gases]. This is a reusable device.

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

Other Devices From This Company#

Primary DI, Brand, Model table
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00073796760069Upper Arm Blood Pressure MonitorHEM-7600T-CD6HEM-7600T-CD62025-07-15
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00073796725310Omron 5 Series Upper Arm Blood Pressure MonitorBP7250CANBP7250CAN2019-07-08
00073796735319Omron 7 Series Upper Arm Blood Pressure MonitorBP7350CANBP7350CAN2019-07-08
00073796745318Omron 10 Series Upper Arm Blood Pressure MonitorBP7450CANBP7450CAN2019-07-08
00073796893101Blood Pressure Monitor BP9310TBP9310T2022-07-01
00073796745530Omron Blood Pressure MonitorBP7455CAN-CD6BP7455CAN-CD62021-09-01
00073796100315Omron 3 Series Upper Arm Blood Pressure MonitorBP7100CANBP7100CAN2019-07-08
00073796146054AC Adapter for digital Blood Pressure UnitsHEM-ADPTW5HEM-ADPTW52016-09-16

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