Direct IV Solutions - IV Start Kit - IV Starter Kit - BD 20G Insyte Catheter, IV Derm - Lynn Medical Instrument Co.

Duns Number:058810771

Device Description: IV Starter Kit - BD 20G Insyte Catheter, IV Derm Transparent Silicone, Tourniquet, Gauze, IV Starter Kit - BD 20G Insyte Catheter, IV Derm Transparent Silicone, Tourniquet, Gauze, Alcohol Prep Pad, & Under Pad

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More Product Details

Catalog Number

2534-20G

Brand Name

Direct IV Solutions - IV Start Kit

Version/Model Number

2534-20G

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)

Yes

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

24d82bb0-07fa-456c-9fae-31a21090811c

Public Version Date

May 01, 2020

Public Version Number

1

DI Record Publish Date

April 23, 2020

Additional Identifiers

Package DI Number

10851491007507

Quantity per Package

100

Contains DI Package

00851491007500

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS

"LYNN MEDICAL INSTRUMENT CO." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 6