True Comfort Pro Pen Needles 4MM 32G - 100ct box. 32G x 4mm Single use disposable pen - HOME AIDE DIAGNOSTICS, INC.

Duns Number:783518983

Device Description: 100ct box. 32G x 4mm Single use disposable pen needle for use with most insulin delivery s 100ct box. 32G x 4mm Single use disposable pen needle for use with most insulin delivery systems. Includes 100 sterile needles individually wrapped.

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More Product Details

Catalog Number

1775

Brand Name

True Comfort Pro Pen Needles 4MM 32G

Version/Model Number

I23204 or INSP32-4

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Device Record Status

Public Device Record Key

d6981b84-f4fc-4b24-be70-ca8cbd6e8d2d

Public Version Date

April 01, 2021

Public Version Number

1

DI Record Publish Date

March 24, 2021

Additional Identifiers

Package DI Number

10850027494064

Quantity per Package

50

Contains DI Package

00850027494067

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Carton

"HOME AIDE DIAGNOSTICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 24
2 A medical device with a moderate to high risk that requires special controls. 44
U Unclassified 11