LPOW

Primary DI
00850063675130
Brand
LPOW
Company
Hangzhou Universal Electronic Co.,Ltd.
Model
GF-MT509
Published
2024-05-28
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
OZKThermometer, Exhaled Breath

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OZKThermometer, Exhaled BreathGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102718000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102718000DIGITAL THERMOMETER; DIGITAL THERMOMETERInternational Regulatory Consultants, LLC (Irc)2010-12-13FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850063675130PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850063675130008500636751308500636751300850063675130

GMDN Terms#

Term, Definition table
TermDefinition
Intermittent electronic patient thermometerA hand-held, battery-powered, electronic instrument designed to measure a patient's body temperature. It may comprise an electronic unit with an attached probe or be a single unit (shaped like an ordinary hand-held capillary thermometer) that detects and converts the changes in temperature into variations of some electrical characteristic, e.g., resistance or voltage. These variations of the electrical characteristics are processed in the electronic circuits and in turn displayed, for a short period, as temperature readings. Thereafter the display will automatically turn off or go into standby mode. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
679945639
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860011164937NTIMT-502C2025-10-16
00860011164944NTIMT-502AMT-5022025-10-16
00860011164951NTIMT-502A2025-10-16
00860011164968NTIMT-502C2025-10-16
00860011164975NTIMT-502C2025-10-16
00860011164982NTIMT-502C2025-10-16
00860011164913BoncareFT-100A2025-03-27
00860011164920BoncareFT-100A2025-03-27
06949395046009BoncareFT-100A2025-03-21
00860007291128None95002022-05-31
00860007291111Familycare 5722021-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00767056156395MABISD-M-S HOLDINGS, INC.OZK2016-09-23
00767056156814MABISD-M-S HOLDINGS, INC.OZK2016-09-23
10767056156392MABISD-M-S HOLDINGS, INC.OZK2016-09-23
10767056156811MABISD-M-S HOLDINGS, INC.OZK2016-09-23
00036800396920TOPCARETopco Associates, LLCOZK2016-09-12
10036800396927TOPCARETopco Associates, LLCOZK2016-09-12
00681131060271RELIONWAL-MART STORES, INC.OZK2016-08-17
10681131060278RELIONWAL-MART STORES, INC.OZK2016-08-17