FDA.reportPublic FDA data

Zephyr

Primary DI
90884521725467
Brand
Zephyr
Company
ZEPHYR TECHNOLOGY LLC
Model
BH3-M2
Catalog number
BH3-M2
Device description
BioModule
Published
2018-01-24
Public version status
Update
Distribution status
Not 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
MHXMONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Cardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
90884521725467PackageGS1999Not in Commercial Distribution
10884521725461PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
9088452172546790884521725467
1088452172546110884521725461

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiograph, professional, single-channelA device intended to be used by a healthcare professional in a clinical setting to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed for recording the electrical signal from only one configuration of electrodes (ECG-leads) at a time (single-channel). It will either include an integrated display or be designed to transmit ECG data to an off-the-shelf device for display; ECG electrodes may be included. Data interpretation and/or data telemetry features might also be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure12 KiloPascal107 KiloPascal
Handling Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-4 Degrees Fahrenheit113 Degrees Fahrenheit
Special Storage Condition, Specify00Keep dry
Special Storage Condition, Specify00Keep dry;
Storage Environment Atmospheric Pressure12 KiloPascal107 KiloPascal
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-4 Degrees Fahrenheit113 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
796678527
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
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
10884521712898ZephyrLIFE HomeSoftware HomeSoftware Home2016-09-24
10884521704817ZephyrBH3-M1BH3-M12016-10-13
10884521712904ZephyrLIFE HospitalSoftware HospitalSoftware Hospital2016-09-24
10884521725461ZephyrBH3-M2BH3-M22018-01-24
10884521712935ZephyrLIFE Home9607.02429607.02422016-09-24
10884521712942ZephyrLIFE Home9607.02439607.02432016-09-24
10884521712966ZephyrLIFE Home9607.02459607.02452016-09-24
10884521712973ZephyrLIFE Home9607.02469607.02462016-09-24
10884521712980ZephyrLIFE Home9607.02589607.02582016-09-24
10884521712997ZephyrLIFE Home9607.02579607.02572016-09-24
10884521712959ZephyrLIFE Home9607.02449607.02442016-09-24
10884521713000ZephyrLIFE Home9607.02599607.02592016-09-24
10884521712911ZephyrLIFE Home9607.02399607.02392016-09-24
10884521712928ZephyrLIFE Home9607.02412016-09-24
10884521758964Zephyr9607-02189607-02182018-01-24
10884521758995Zephyr9607-02159607-02152018-01-24
10884521706026ZephyrBIOMODULE HOLDERBIOMODULE HOLDER2016-09-24

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Primary DI, Brand, Company table
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