Medline Industries, Inc. - EPIDURAL PACK B14 - MEDLINE INDUSTRIES, INC.

Duns Number:025460908

Device Description: EPIDURAL PACK B14

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More Product Details

Catalog Number

DYNJ59248

Brand Name

Medline Industries, Inc.

Version/Model Number

DYNJ59248

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)

Yes

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

OFT

Product Code Name

Spinal epidural anesthesia kit

Device Record Status

Public Device Record Key

9f299f0f-f9ac-4198-abd4-f6ae8872fa83

Public Version Date

June 17, 2022

Public Version Number

4

DI Record Publish Date

September 30, 2018

Additional Identifiers

Package DI Number

40889942974062

Quantity per Package

11

Contains DI Package

10889942974061

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