FDA.reportPublic FDA data

FLTR

Primary DI
10840061480116
Brand
FLTR
Company
Shenzhen Pacom Medical Instruments Co., Ltd.
Model
PC801
Device description
Model: PC801; Brand: FLTR; One inner packing box contains 4 device; One outer packing box contains 5 inner packing boxes. Per outer packing box can pack 20 devices.
Published
2020-09-26
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
K190717000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190717000Infrared Thermometer, model: PC808Shenzhen Pacom Medical Instruments Co., Ltd.2019-12-13FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840061480116PackageGS14In Commercial Distribution
20840061480113PackageGS15In Commercial Distribution
00840061480119PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084006148011610840061480116
2084006148011320840061480113
00840061480119008400614801198400614801190840061480119

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
10840061482813FLTRPC8282020-08-17
10840061486828FLTRPC8682020-07-17
10840061486811FLTRPC8682020-05-25
00840061480911CarounePC8092019-10-31
10840061482806Infrared ThermometerPC8282020-04-15
10840061486804Infrared ThermometerPC8682020-04-15

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Primary DI, Brand, Company table
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