FDA.reportPublic FDA data

Polygreen

Primary DI
04252010600015
Brand
Polygreen
Company
Dongguan Polygreen Technology Co., Ltd.
Model
KD-PC-0001
Device description
Probe cover
Published
2023-06-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
FLLThermometer, Electronic, Clinical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04252010600015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04252010600015042520106000154252010600015

GMDN Terms#

Term, Definition table
TermDefinition
Electronic thermometer probe coverA device intended to be used as a physical barrier between the patient and the probe of a thermometer that uses electronics to create the measurement, e.g., a tympanic (in-the-ear) or electronic (body) thermometer, to prevent cross-contamination between patients. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
543045966
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04252010621003PolygreenKD-21002023-06-08
04252010661207PolygreenKP-61202023-06-08
04252010662105PolygreenKP-62102023-06-08
04252010670001PolygreenKP-70002023-06-08
04252010681205PolygreenKI-81202023-06-08
24250218582809polygreenKI-82802020-03-25
34250218582806polygreenKI-82802020-03-25
04250218582805polygreenKi-82802020-03-23
14250218582802polygreenKI-82802020-03-23
14250218520705PolygreenKD-20702020-11-03
24250218520702PolygreenKD-20702020-11-03
04250218576729PolygreenKP-76722020-09-11
04250218520708PolygreenKD-20702020-09-10
04250218566508PolygreenKP-66502020-09-10
04250218575906PolygreenKP-75902020-09-10
04250218591005PolygreenKN-91002020-09-10
04250218592101PolygreenKN-92102020-09-10
04250218593115PolygreenKN-93112020-09-10
04250218520418PolygreenKD-2042020-04-20
14250218520415PolygreenKD-2042020-04-20

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.FLL2026-06-03
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.FLL2026-06-02
06926347900459joybabeShenzhen Brav Electronic Technologies Co., Ltd.FLL2026-06-01
06942284618073One Step®JOYTECH HEALTHCARE CO.,LTDFLL2026-05-29
00884392020613Safety 1stDOREL JUVENILE GROUP, INC.FLL2026-05-28
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B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
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B3945700048100WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700063010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
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B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
08698870325211FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22