FDA.reportPublic FDA data

Ultraview DM3

Primary DI
00851920007002
Brand
Ultraview DM3
Company
ZOE MEDICAL INCORPORATED
Model
91330-M
Catalog number
175-6100
Device description
The Ultraview DM3 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients.
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQAOximeter
DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093802000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093802000ULTRAVIEW DM3 MONITORZoe Medical, Inc.2010-04-09DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851920007002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851920007002008519200070028519200070020851920007002

GMDN Terms#

Term, Definition table
TermDefinition
Transportable physiologic monitoring systemAn assembly of battery-powered devices designed for continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of a patient in transit [e.g., during transport to, between, or within a hospital(s)]. It typically includes a recorder, amplifier, display monitor, and patient leads/attachments; it may also be used by the bedside where it is normally connected to the mains electricity.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
978-887-4013customersupport@zoemedical.com

Regulatory Flags#

DUNS number
848429929
Device count
1
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851920007170NAECG Lead, 3 meter421-00462016-09-22
00851920007200NAECG Lead, 1 meter01-02-09272016-09-22
00851920007217NAECG Lead, 1 meter01-02-09232016-09-22
00851920007224NAECG Lead, 1 meter01-02-09222016-09-22
00851920007255NAECG Lead, 1 meter01-02-09222017-01-28
00851920007262NAECG Lead, 1 meter01-02-09252017-01-31
00851920007446740 SELECT740 SELECT-0N0E001-02-10252022-09-27
00851920007408740 SELECT740 SELECT-XMF0W01-02-10332020-08-12
00851920007415740 SELECT740 SELECT-XM0EW01-02-10482020-08-12
00851920007422740 SELECT740 SELECT-XN0EW01-02-10492020-08-12
00851920007392740 SELECT740 SELECT-XNFE001-02-10212020-05-04
00851920007309DM491331-N91331-N2019-06-01
00851920007316DM491331-NF91331-NF2019-06-01
00851920007323DM491331-NW91331-NW2019-06-01
00851920007330DM491331-NFW91331-NFW2019-06-01
00851920007385740 SELECT740 SELECT-0NF0001-02-10142019-08-27
00851920007347DM491331-M91331-M2019-06-15
00851920007354DM491331-MF91331-MF2019-06-15
00851920007361DM491331-MW91331-MW2019-06-15
00851920007378DM491331-MFW91331-MFW2019-06-15

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Primary DI, Brand, Company table
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