FDA.reportPublic FDA data

Caroune

Primary DI
08400614000007
Brand
Caroune
Company
Shenzhen Pacom Medical Instruments Co., Ltd.
Model
PC809
Device description
Name: Multifunctional Infrared Thermometer Model: PC809 Brand: Caroune Test Sites: Ear, Forehead Battery: 2pcs AAA batteries
Published
2019-10-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
FLLThermometer, Electronic, Clinical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172889000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172889000Infrared ThermometerShenzhen Pacom Medical Instruments Co., Ltd.2018-05-25FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18400614000004PackageGS1100In Commercial Distribution
08400614000007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1840061400000418400614000004
08400614000007084006140000078400614000007

GMDN Terms#

Term, Definition table
TermDefinition
Infrared patient thermometer, ear/skinA hand-held, battery-powered, electronic instrument designed to measure: 1) the temperature of a patient's ear canal, typically to estimate the internal (core) temperature; and 2) the temperature of a site on the skin (e.g., axilla, forehead), by measurement of body infrared emissions. It typically includes both a skin-surface tip and an intra-aural tip. This device is intended for use in the home or healthcare facility. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
421356348
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840061486807Infrared ThermometerPC8682020-04-15
00840061480119FLTRPC8012020-09-26
00840061481604Infrared ThermometerPC8162021-05-01
00840061480904Infrared ThermometerPC8092020-04-15
10840061481601Infrared ThermometerPC8162021-05-01
00840061482830BionsoPC8282021-05-01
10840061482837BionsoPC8282021-05-01
00840061482908Infrared ThermometerPC8292021-04-17
10840061482905Infrared ThermometerPC8292021-04-17
00840061482809Infrared ThermometerPC8282020-04-15
00840061482816FLTRPC8282020-08-17
00840061486814FLTRPC8682020-05-25
00840061486821FLTRPC8682020-07-17
00840061482823FLTRPC8282020-08-17
10840061480116FLTRPC8012020-09-26
10840061482813FLTRPC8282020-08-17
10840061486828FLTRPC8682020-07-17
10840061486811FLTRPC8682020-05-25
00840061480911CarounePC8092019-10-31
10840061482806Infrared ThermometerPC8282020-04-15

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Primary DI, Brand, Company table
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