FDA.reportPublic FDA data

Starling

Primary DI
27290013030041
Brand
Starling
Company
CHEETAH MEDICAL (ISRAEL) LTD
Model
CMS10
Catalog number
CMS10
Device description
The Starling sensors are accessories to the Starling Monitor which provides continuous non-invasive monitoring of Cardiac Output and other key hemodynamic parameters of cardiac function.
Published
2023-12-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXGCOMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXGComputer, Diagnostic, Pre-Programmed, Single-FunctionCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101487000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101487000CHEETAH NICOM SYSTEMCheetah Medical, Inc.2010-07-02DXG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
27290013030041PrimaryGS10
07290013030047Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2729001303004127290013030041
07290013030047072900130300477290013030047

GMDN Terms#

Term, Definition table
TermDefinition
Multiple vital physiological parameter monitoring system, clinicalAn assembly of electrically-powered devices designed to be used by a healthcare professional in a clinical setting for intermittent or continuous assessment of several vital physiologic parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse rate, temperature, haemoglobin oxygen saturation (SpO2)]. It includes both physiological parameter sensors, probes, and/or electrodes (e.g., ECG electrodes, blood pressure cuff) and processing hardware with dedicated software. It typically incorporates a monitoring screen, but may alternatively be connected to an off-the-shelf device for display; it is not intended to be worn on the body.

Contacts#

Phone, Email table
PhoneEmail
+1(800)422-9837medinfo_medproducts@baxter.com

Regulatory Flags#

DUNS number
533390019
Device count
10
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290013030030Starling SVCMM-ST5CMM-ST52021-04-07
17290013030044StarlingCMS25CMS252023-12-12
47290013030045StarlingCMS5CMS52023-12-12
07290013030047StarlingCMS5CMS52023-12-12
77290013030046StarlingCMS5CMS52023-12-12
07290013030269StarlingCMMST5CMMST52022-08-12
07290013030290StarlingCMMST5SCMMST5S2022-08-12
72900130302906Starling Monitor with SpO2 ModuleCMMST5SCMMST5S2021-04-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850044487042Retia MedicalRETIA MEDICAL, LLCDXG2026-04-16
00850044487103Retia MedicalRETIA MEDICAL, LLCDXG2026-04-16
00850044487110Retia MedicalRETIA MEDICAL, LLCDXG2026-04-16
00850044487127Retia MedicalRETIA MEDICAL, LLCDXG2026-04-16
00850044487134Retia MedicalRETIA MEDICAL, LLCDXG2026-04-16
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyDXG2026-04-15
00198953049181NAGE Healthcare Finland OyDXG2026-01-05
00198953066560NAGE Healthcare Finland OyDXG2026-01-05
07290020154101BB-613W Wrist-MonitorBIOBEAT TECHNOLOGIES LTDDXG2025-03-05
07290020154309BB-613 H@H kitBIOBEAT TECHNOLOGIES LTDDXG2025-03-05
17290020154009BB-613P Chest-Monitor 40-Unit MultipackBIOBEAT TECHNOLOGIES LTDDXG2025-03-05
00843997001823LiDCOMASIMO CORPORATIONDXG2024-07-26
00843997002882LiDCOMASIMO CORPORATIONDXG2024-07-26
00843997017428LiDCOMASIMO CORPORATIONDXG2024-07-26
00843997017435LiDCOMASIMO CORPORATIONDXG2024-07-26
00843997017190LiDCOMASIMO CORPORATIONDXG2024-07-26
09120073933027CNAP® Monitor 500 HDCNSystems Medizintechnik GmbHDXG2024-07-10
00850044487011Retia MedicalRETIA MEDICAL, LLCDXG2024-02-01
17290013030044StarlingCHEETAH MEDICAL (ISRAEL) LTDDXG2023-12-12
47290013030045StarlingCHEETAH MEDICAL (ISRAEL) LTDDXG2023-12-12
07290013030047StarlingCHEETAH MEDICAL (ISRAEL) LTDDXG2023-12-12
77290013030046StarlingCHEETAH MEDICAL (ISRAEL) LTDDXG2023-12-12
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyDXG2023-04-19
00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyDXG2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyDXG2023-04-19
00195278524089NAGE Healthcare Finland OyDXG2023-04-19
00850044487004Retia MedicalRETIA MEDICAL, LLCDXG2023-02-21
09120073932990CNAP® Monitor 500 HDCNSystems Medizintechnik GmbHDXG2022-06-09
00840682146111CARESCAPE B650GE Healthcare Finland OyDXG2022-05-13
00840682146135CARESCAPE B450GE Healthcare Finland OyDXG2022-05-13