SURFLO - Surflo Winged Infusion Set - TERUMO CORPORATION

Duns Number:690543319

Device Description: Surflo Winged Infusion Set

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More Product Details

Catalog Number

-

Brand Name

SURFLO

Version/Model Number

SV*23BLS

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

FPA

Product Code Name

Set, administration, intravascular

Device Record Status

Public Device Record Key

b8c9bc5c-466c-4bb1-a4d6-e02a040ccc01

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 09, 2016

Additional Identifiers

Package DI Number

54987350761090

Quantity per Package

5

Contains DI Package

34987350761096

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"TERUMO CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 11
2 A medical device with a moderate to high risk that requires special controls. 364
3 A medical device with high risk that requires premarket approval 29