Pure Comfort Insulin Pen Needles 32G 4mm 50cnt

GUDID 10860003125516

Insulin Pen Needles 32G 4mm 50cnt

HOME AIDE DIAGNOSTICS, INC.

Hypodermic needle, single-use
Primary Device ID10860003125516
NIH Device Record Key149763af-15f3-4e9f-be84-9573d6a3e54a
Commercial Distribution StatusIn Commercial Distribution
Brand NamePure Comfort Insulin Pen Needles 32G 4mm 50cnt
Version Model NumberINSP32-4
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

Phone1-800-915-0116
Emailinfo@homeaide.us
Phone1-800-915-0116
Emailinfo@homeaide.us
Phone1-800-915-0116
Emailinfo@homeaide.us
Phone1-800-915-0116
Emailinfo@homeaide.us
Phone1-800-915-0116
Emailinfo@homeaide.us
Phone1-800-915-0116
Emailinfo@homeaide.us
Phone1-800-915-0116
Emailinfo@homeaide.us
Phone1-800-915-0116
Emailinfo@homeaide.us
Phone1-800-915-0116
Emailinfo@homeaide.us
Phone1-800-915-0116
Emailinfo@homeaide.us
Phone1-800-915-0116
Emailinfo@homeaide.us
Phone1-800-915-0116
Emailinfo@homeaide.us
Phone1-800-915-0116
Emailinfo@homeaide.us
Phone1-800-915-0116
Emailinfo@homeaide.us
Phone1-800-915-0116
Emailinfo@homeaide.us
Phone1-800-915-0116
Emailinfo@homeaide.us
Phone1-800-915-0116
Emailinfo@homeaide.us

Device Dimensions

Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
GS100860003125519 [Primary]
GS110860003125516 [Package]
Contains: 00860003125519
Package: outer carton [50 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

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 Date2020-03-05
Device Publish Date2020-02-26

Devices Manufactured by HOME AIDE DIAGNOSTICS, INC.

10850027494347 - True Comfort Knee Compression Wrap2024-10-16 True Comfort Knee Compression Wrap
10850027494354 - Pure Comfort Leg Massager2024-10-16 Pure Comfort Leg Massager
01085027494383 - Ultra Comfort Body Massager2024-10-16 Ultra Comfort Body Massager
10850027494453 - Pro Health Track: Bluetooth Blood Pressure Monitor2024-10-16 Arm-type fully automatic digital blood pressure monitor. LCD digital display. Oscillometric measurement method. 0mmHg~300mmHg pr
10850027494477 - Pro Comfort Lumbar Support2024-10-16 Pro Comfort Lumbar Support
10850027494484 - Ultra Comfort Heating Patch2024-10-16 Ultra Comfort Heating Patch
10850027494491 - Ultra Comfort Heated Socks2024-10-16 Ultra Comfort Heated Socks
10850027494521 - Total Comfort Elbow Support Sleeve LG2024-10-16 Total Comfort Elbow Support Sleeve LG

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.