Infusion Safety Products, Inc. - 19ga x 1.50" RA, Non-Coring Safety Huber Needle - INFUSION SAFETY PRODUCTS, INC.

Duns Number:024502047

Device Description: 19ga x 1.50" RA, Non-Coring Safety Huber Needle Infusion Set with 8.5" tubing and a "Y" po 19ga x 1.50" RA, Non-Coring Safety Huber Needle Infusion Set with 8.5" tubing and a "Y" port with a non-vented cap, Latex Free, Non-DEHP Tubing, Lipid Resistant, Rated to 300 psi, Approx. Priming Volume .35cc

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More Product Details

Catalog Number

-

Brand Name

Infusion Safety Products, Inc.

Version/Model Number

ISP1915Y

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"

-

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

K170881,K170881

Product Code Details

Product Code

PTI

Product Code Name

Non-Coring (Huber) Needle

Device Record Status

Public Device Record Key

bf3d6654-6081-4356-a030-34fa2efcf1fa

Public Version Date

February 26, 2020

Public Version Number

3

DI Record Publish Date

July 20, 2018

Additional Identifiers

Package DI Number

10856673008150

Quantity per Package

25

Contains DI Package

00856673008153

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"INFUSION SAFETY PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 6