easycare - IV Start Kit w/3M™ Tegaderm™ #1624 & PDI - SYNCHRONIS MEDICAL, LLC

Duns Number:080160207

Device Description: IV Start Kit w/3M™ Tegaderm™ #1624 & PDI Prevantics® Swab

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More Product Details

Catalog Number

4502-50000

Brand Name

easycare

Version/Model Number

4502-50000

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

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

LRS

Product Code Name

I.V. Start Kit

Device Record Status

Public Device Record Key

02bc52d1-10d1-49d8-9449-482ccebef178

Public Version Date

April 27, 2020

Public Version Number

1

DI Record Publish Date

April 17, 2020

Additional Identifiers

Package DI Number

00850015884153

Quantity per Package

100

Contains DI Package

00850015884115

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"SYNCHRONIS MEDICAL, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 12