INTRAVENOUS INFUSION STARTER SET - 18 GA Catheter 1 ea20 GA Catheter - Safeguard US Operating, LLC

Duns Number:118492643

Device Description: 18 GA Catheter 1 ea20 GA Catheter 1 eaSaline Flush (5cc pre-filled 18 GA Catheter 1 ea20 GA Catheter 1 eaSaline Flush (5cc pre-filled syringe) 1 eaPovidone Prep Pad 1 eaAlcohol Prep Pad 2 eaIV Administration Set 1 eaNeedle Free Valve with Luer Lock 1 eaConstricting Band 1 eaIV Catheter Dressing 1eaTransparent Film Dressing 1 eaAdhesive Bandage 1 ea2"x2" Gauze Pad (2 pack) 1 ea

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More Product Details

Catalog Number

80-100

Brand Name

INTRAVENOUS INFUSION STARTER SET

Version/Model Number

12

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

-

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

0f57b0e7-de01-457b-bbd8-8bfafd999220

Public Version Date

October 26, 2022

Public Version Number

1

DI Record Publish Date

October 18, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SAFEGUARD US OPERATING, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 217
2 A medical device with a moderate to high risk that requires special controls. 48