Pro's Combo™ 768-619-11ATLKIT

GUDID 00634782599362

Pro's Combo 760/619 Teal,Free 353S

AMERICAN DIAGNOSTIC CORP

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Primary Device ID00634782599362
NIH Device Record Key919e6e92-a78e-48b8-9486-b1d55d62ac55
Commercial Distribution StatusIn Commercial Distribution
Brand NamePro's Combo™
Version Model Number768-619-11ATLKIT
Catalog Number768-619-11ATLKIT
Company DUNS108999095
Company NameAMERICAN DIAGNOSTIC CORP
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100634782097981 [Primary]
GS100634782599362 [Package]
Contains: 00634782097981
Package: Master Case [3 Units]
In Commercial Distribution

FDA Product Code

LDEStethoscope, Manual

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-09
Device Publish Date2021-07-30