FDA.reportPublic FDA data

IRIS-XP

Primary DI
00191237000069
Brand
IRIS-XP
Company
Medicore Co., Ltd.
Model
IRIS
Catalog number
IRIS
Published
2021-11-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LHQSystem, Telethermographic (Adjunctive Use)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHQSystem, Telethermographic (Adjunctive Use)Obstetrics/Gynecology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212412000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212412000IRIS-XPMedicore Co., Ltd.2021-09-13LHQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10191237000066PackageGS11In Commercial Distribution
00191237000069PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1019123700006610191237000066
00191237000069001912370000691912370000690191237000069

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity20 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+823180277070bkyoo@medi-core.com

Regulatory Flags#

DUNS number
688247753
Device count
1
DM exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00191237000014SA-3000PSA-3000PSA-3000P2019-04-10
10191237000011SA-3000PSA-3000PSA-3000P2019-04-10
00191237000038Max PulseMax PulseMax Pulse2019-03-05
40191237000036Max PulseMax PulseMax Pulse2019-03-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B783706400170601189MedithermMeditherm IncorporatedLHQ2026-05-18
B783706400170601185MedithermMeditherm IncorporatedLHQ2026-05-01
B783706400170601158MedithermMeditherm IncorporatedLHQ2026-03-31
B783706400170601159MedithermMeditherm IncorporatedLHQ2026-03-23
B783706400170601152MedithermMeditherm IncorporatedLHQ2026-03-18
B783706400170601154MedithermMeditherm IncorporatedLHQ2026-03-18
00860008801906ThermPixUSA THERM, INC.LHQ2026-01-27
B783706400170601148MedithermMeditherm IncorporatedLHQ2025-12-22
B783706400170601149MedithermMeditherm IncorporatedLHQ2025-12-22
08908019450118BreastHealth-100NIRAMAI HEALTH ANALYTIX PRIVATE LIMITEDLHQ2025-11-21
B783706400170601151MedithermMeditherm IncorporatedLHQ2025-07-30
B783706400170601141MedithermMeditherm IncorporatedLHQ2025-07-23
B783706400170601142MedithermMeditherm IncorporatedLHQ2025-07-23
B783706400170601145MedithermMeditherm IncorporatedLHQ2025-07-23
B783706400170601146MedithermMeditherm IncorporatedLHQ2025-07-23
B783706400170601147MedithermMeditherm IncorporatedLHQ2025-07-23
B783706400170601132MedithermMeditherm IncorporatedLHQ2025-07-02
B783706400170601144MedithermMeditherm IncorporatedLHQ2025-07-02
B783706400170601140MedithermMeditherm IncorporatedLHQ2025-05-08
B783706400170601143MedithermMeditherm IncorporatedLHQ2025-05-08
06429810718037ThermidasTherMidas OyLHQ2025-04-08
06429810718044ThermidasTherMidas OyLHQ2025-04-08
B783706400170601133MedithermMeditherm IncorporatedLHQ2025-02-24
B783706400170601136MedithermMeditherm IncorporatedLHQ2025-02-24
B783706400170601137MedithermMeditherm IncorporatedLHQ2025-02-24
08908019450057SMILE-100 SystemNIRAMAI HEALTH ANALYTIX PRIVATE LIMITEDLHQ2025-02-18
B783706400170601138MedithermMeditherm IncorporatedLHQ2024-10-25
B783706400170601135MedithermMeditherm IncorporatedLHQ2024-09-09
10853818007504USB C AdapterPRECISION BIOMETRICS INCLHQ2024-09-03
00853818007491USB A to C CablePRECISION BIOMETRICS INCLHQ2024-09-03