True Comfort Insulin Pen Needles 31G 5mm

GUDID 10860000526545

True Comfort Insulin Pen Needles 31G 5mm

HOME AIDE DIAGNOSTICS, INC.

Subcutaneous infusion/injection port needle
Primary Device ID10860000526545
NIH Device Record Key6e0a02be-4970-45f4-b5a2-214938216a6a
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrue Comfort Insulin Pen Needles 31G 5mm
Version Model Number6548
Company DUNS783518983
Company NameHOME AIDE DIAGNOSTICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone8009150116
Emailinfo@homeaide.us
Phone8009150116
Emailinfo@homeaide.us
Phone8009150116
Emailinfo@homeaide.us
Phone8009150116
Emailinfo@homeaide.us
Phone8009150116
Emailinfo@homeaide.us
Phone8009150116
Emailinfo@homeaide.us
Phone8009150116
Emailinfo@homeaide.us
Phone8009150116
Emailinfo@homeaide.us
Phone8009150116
Emailinfo@homeaide.us
Phone8009150116
Emailinfo@homeaide.us
Phone8009150116
Emailinfo@homeaide.us
Phone8009150116
Emailinfo@homeaide.us
Phone8009150116
Emailinfo@homeaide.us
Phone8009150116
Emailinfo@homeaide.us
Phone8009150116
Emailinfo@homeaide.us
Phone8009150116
Emailinfo@homeaide.us
Phone8009150116
Emailinfo@homeaide.us

Device Dimensions

Needle Gauge31 Gauge
Needle Gauge31 Gauge
Needle Gauge31 Gauge
Needle Gauge31 Gauge
Needle Gauge31 Gauge
Needle Gauge31 Gauge
Needle Gauge31 Gauge
Needle Gauge31 Gauge
Needle Gauge31 Gauge
Needle Gauge31 Gauge
Needle Gauge31 Gauge
Needle Gauge31 Gauge
Needle Gauge31 Gauge
Needle Gauge31 Gauge
Needle Gauge31 Gauge
Needle Gauge31 Gauge
Needle Gauge31 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
GS100860000526548 [Primary]
GS110860000526545 [Package]
Contains: 00860000526548
Package: Case [50 Units]
In Commercial Distribution

FDA Product Code

FMINeedle, Hypodermic, Single Lumen

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-16
Device Publish Date2024-10-08

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