Medline - KENDALL DL DISPOSABLE SPACELABS DIRECT - MEDLINE INDUSTRIES, INC.

Duns Number:025460908

Device Description: KENDALL DL DISPOSABLE SPACELABS DIRECT

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More Product Details

Catalog Number

33133R

Brand Name

Medline

Version/Model Number

33133R

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

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

IKD

Product Code Name

CABLE, ELECTRODE

Device Record Status

Public Device Record Key

45a60eb8-e242-44a1-ac2a-9fe269902f90

Public Version Date

July 25, 2022

Public Version Number

1

DI Record Publish Date

July 15, 2022

Additional Identifiers

Package DI Number

40888277313126

Quantity per Package

10

Contains DI Package

10888277313125

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"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