FDA.reportPublic FDA data

Disposable Thermometer Cover and Sheaths

Primary DI
06972543480103
Brand
Disposable Thermometer Cover and Sheaths
Company
KANG ZE INDUSTRIAL CO., LTD
Model
12028
Device description
The Disposable Thermometer Covers and Sheaths are intended for use as barriers between digital or mercury thermometers and users’ rectum or oral cavities to avoid the possible contamination and infection during temperature measuring. These covers and sheaths are non-sterile and intended for single use only.
Published
2019-08-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
FLKThermometer, Clinical Mercury
FLLThermometer, Electronic, Clinical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLKThermometer, Clinical MercuryGeneral Hospital2
FLLContinuous Measurement ThermometerGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112289000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112289000DISPOSABLE THERMOMETER COVERS AND SHEATHSKang ZE Industrial Co. Limited2011-12-16FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972543480103PrimaryGS10
06972543480073Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972543480103069725434801036972543480103
06972543480073069725434800736972543480073

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.

Contacts#

Phone, Email table
PhoneEmail
+86076922386952kangzecover@163.com

Regulatory Flags#

DUNS number
542345014
Device count
5000
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
06972543480110Disposable Thermometer Cover and Sheaths90282019-08-23
06972543480127Disposable Thermometer Cover and Sheaths92252019-08-23

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