Rectal Temperature Digital Thermometer 16813

GUDID 20612606001530

Rectal Temperature Digital Thermometer

KERMA MEDICAL PRODUCTS, INC.

Intermittent electronic patient thermometer
Primary Device ID20612606001530
NIH Device Record Keyed4a891d-91c1-4f1f-b6c0-fd0edcec4d48
Commercial Distribution StatusIn Commercial Distribution
Brand NameRectal Temperature Digital Thermometer
Version Model Number16813
Catalog Number16813
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100612606001536 [Primary]
GS120612606001530 [Package]
Contains: 00612606001536
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 Thermometer2018-07-06 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 Thermometer2018-07-06Rectal Temperature Digital Thermometer
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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