PremierPro - IV Start Kit Pediatric: Tegaderm™ 1682 - SVS LLC

Duns Number:831375089

Device Description: IV Start Kit Pediatric: Tegaderm™ 1682 Securement, IV Change Label, 2"x2" 4-ply Gauze, Ch IV Start Kit Pediatric: Tegaderm™ 1682 Securement, IV Change Label, 2"x2" 4-ply Gauze, ChloraPrep® Sepp® 1ml, Prep Pad, Transpore™ Tape .75"x18", Orange Tourniquet .75"x18"

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More Product Details

Catalog Number

7248

Brand Name

PremierPro

Version/Model Number

7248

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)

-

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

a02ba54e-079d-4235-8caf-964275542257

Public Version Date

September 07, 2020

Public Version Number

1

DI Record Publish Date

August 29, 2020

Additional Identifiers

Package DI Number

10818566016949

Quantity per Package

100

Contains DI Package

00818566016942

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case

"SVS LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 486
2 A medical device with a moderate to high risk that requires special controls. 177
U Unclassified 1