Dual Scale Digital Thermometer 16809

GUDID 00612606001505

Dual Scale Digital Thermometer, 60 second read, for oral, rectal, or axillary use

KERMA MEDICAL PRODUCTS, INC.

Intermittent electronic patient thermometer
Primary Device ID00612606001505
NIH Device Record Keye95ee900-aa8c-4f7c-b0c3-b8f4c7bcd103
Commercial Distribution StatusIn Commercial Distribution
Brand NameDual Scale Digital Thermometer
Version Model Number16809
Catalog Number16809
Company DUNS787328772
Company NameKERMA MEDICAL PRODUCTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100612606001505 [Primary]
GS110612606001502 [Package]
Package: [24 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FLLThermometer, Electronic, Clinical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-08-18

Devices Manufactured by KERMA MEDICAL PRODUCTS, INC.

00612606001505 - Dual Scale Digital Thermometer2018-07-06Dual Scale Digital Thermometer, 60 second read, for oral, rectal, or axillary use
00612606001505 - Dual Scale Digital Thermometer2018-07-06 Dual Scale Digital Thermometer, 60 second read, for oral, rectal, or axillary use
20612606001516 - Oral Temperature Digital Thermometer2018-07-06 Dual Scale Oral Digital Thermometer, 60 second read
20612606001523 - Oral Temperature Digital Thermometer2018-07-06 Dual Scale Oral Digital Thermometer with 20 Probe Covers, 60 second read
20612606001530 - Rectal Temperature Digital Thermometer2018-07-06 Rectal Temperature Digital Thermometer
20612606001547 - Rectal Digital Thermometer2018-07-06 Dual Scale Rectal Digital Thermometer with 20 Probe Covers, 60 second read

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