MedStream - ADMIN SET 92IN FLOW REGULATOR - MEDICAL SPECIALTIES DISTRIBUTORS, LLC

Duns Number:153608369

Device Description: ADMIN SET 92IN FLOW REGULATOR

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More Product Details

Catalog Number

MS755

Brand Name

MedStream

Version/Model Number

MS755

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Device Record Status

Public Device Record Key

ec5ecdd5-5d48-4724-ac15-1ec9d82890d1

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

20842472102707

Quantity per Package

6

Contains DI Package

10842472102700

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"MEDICAL SPECIALTIES DISTRIBUTORS, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 202
2 A medical device with a moderate to high risk that requires special controls. 86