Syringe MicroSet with Filter - 110 in. (280 cm) Microset with Filter - yellow - CME AMERICA LLC

Duns Number:002125419

Device Description: 110 in. (280 cm) Microset with Filter - yellow stripe, For Use with the BodyGuard® Infusio 110 in. (280 cm) Microset with Filter - yellow stripe, For Use with the BodyGuard® Infusion Pump

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More Product Details

Catalog Number

-

Brand Name

Syringe MicroSet with Filter

Version/Model Number

A100-163XSFL

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 15, 2020

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

-

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

1f6b53cd-ae81-489b-a350-568122fd5863

Public Version Date

November 16, 2020

Public Version Number

4

DI Record Publish Date

June 16, 2017

Additional Identifiers

Package DI Number

10818666020280

Quantity per Package

50

Contains DI Package

00818666020283

Package Discontinue Date

October 15, 2020

Package Status

Not in Commercial Distribution

Package Type

Case

"CME AMERICA LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 125