Adtemp™ - ADTEMP II, Dual Scale, Oral,Dig Therm, Blue, 30s, - AMERICAN DIAGNOSTIC CORP

Duns Number:108999095

Device Description: ADTEMP II, Dual Scale, Oral,Dig Therm, Blue, 30s, Disp pkg

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More Product Details

Catalog Number

413BQ

Brand Name

Adtemp™

Version/Model Number

413BQ

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K940686,K940686,K940686

Product Code Details

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Device Record Status

Public Device Record Key

a593a079-ad78-4202-9f7e-e99cffd51717

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 21, 2016

Additional Identifiers

Package DI Number

00634782584368

Quantity per Package

12

Contains DI Package

00634782884369

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case

"AMERICAN DIAGNOSTIC CORP" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2395
2 A medical device with a moderate to high risk that requires special controls. 1769