Medline - THERMOMETER,DIGITAL,ORAL,20 COVERS,30SEC - MEDLINE INDUSTRIES, INC.

Duns Number:025460908

Device Description: THERMOMETER,DIGITAL,ORAL,20 COVERS,30SEC

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More Product Details

Catalog Number

MDS9928

Brand Name

Medline

Version/Model Number

MDS9928

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"

Yes

For Single-Use

Yes

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

K173113,K183431,K211931

Product Code Details

Product Code

FLL

Product Code Name

Thermometer, electronic, clinical

Device Record Status

Public Device Record Key

351a5f9e-e057-48eb-9a6a-5ec8412f695d

Public Version Date

April 08, 2022

Public Version Number

1

DI Record Publish Date

March 31, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDLINE INDUSTRIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 38540
2 A medical device with a moderate to high risk that requires special controls. 85094
3 A medical device with high risk that requires premarket approval 2
U Unclassified 7