FDA.reportPublic FDA data

Starling SV

Primary DI
07290013030030
Brand
Starling SV
Company
CHEETAH MEDICAL (ISRAEL) LTD
Model
CMM-ST5
Catalog number
CMM-ST5
Device description
A portable, non-invasive cardiac output (CO) monitoring device.
Published
2021-04-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSBPlethysmograph, ImpedanceCardiovascular2
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083093000
K103166000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083093000CHEETAH RELIANTCheetah Medical, Inc.2008-12-15DSB
K103166000CHEETAH RELIANTCheetah Medical, Inc.2011-01-25DSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290013030030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290013030030072900130300307290013030030

GMDN Terms#

Term, Definition table
TermDefinition
Impedance cardiographA device that records the variations in thoracic electrical impedance caused by the activity of the heart muscle, usually detected at the body surface. A current is passed through the body and the product of this current and the body impedance is the electrical potential difference between two sensing electrodes. The graphic representation of the variation of the impedance with time is recorded in a diagram (impedance cardiogram). It is used to study the action of the heart muscle, for diagnosis of specific cardiac abnormalities, and to reveal trends or changes in heart function, especially cardiac output. Some types may include additional measurements (e.g., pulse oximetry, blood pressure).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity50 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
999-999-9999xx@xx.xx
+1 360 828-8685starling_rma@baxter.com

Regulatory Flags#

DUNS number
533390019
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17290013030044StarlingCMS25CMS252023-12-12
27290013030041StarlingCMS10CMS102023-12-12
47290013030045StarlingCMS5CMS52023-12-12
07290013030047StarlingCMS5CMS52023-12-12
77290013030046StarlingCMS5CMS52023-12-12
07290013030269StarlingCMMST5CMMST52022-08-12
07290013030290StarlingCMMST5SCMMST5S2022-08-12
72900130302906Starling Monitor with SpO2 ModuleCMMST5SCMMST5S2021-04-07

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Primary DI, Brand, Company table
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