True Comfort Pro Pen Needles 5MM 31G 1638

GUDID 10850027494071

100ct box. 31G x 5mm Sterile Single use disposable pen needle for use with most insulin delivery systems. Includes 100 sterile needles individually wrapped.

HOME AIDE DIAGNOSTICS, INC.

Hypodermic needle, single-use
Primary Device ID10850027494071
NIH Device Record Key1d00327d-d1cd-42f6-8154-0e5402ca518f
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrue Comfort Pro Pen Needles 5MM 31G
Version Model NumberI12015 or INSP31-5
Catalog Number1638
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

Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Pens Needles are disposable needles and should be discarded after each use. Store at room temperature in a dry cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Pens Needles are disposable needles and should be discarded after each use. Store at room temperature in a dry cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Pens Needles are disposable needles and should be discarded after each use. Store at room temperature in a dry cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Pens Needles are disposable needles and should be discarded after each use. Store at room temperature in a dry cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Pens Needles are disposable needles and should be discarded after each use. Store at room temperature in a dry cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Pens Needles are disposable needles and should be discarded after each use. Store at room temperature in a dry cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Pens Needles are disposable needles and should be discarded after each use. Store at room temperature in a dry cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Pens Needles are disposable needles and should be discarded after each use. Store at room temperature in a dry cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Pens Needles are disposable needles and should be discarded after each use. Store at room temperature in a dry cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Pens Needles are disposable needles and should be discarded after each use. Store at room temperature in a dry cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Pens Needles are disposable needles and should be discarded after each use. Store at room temperature in a dry cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Pens Needles are disposable needles and should be discarded after each use. Store at room temperature in a dry cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Pens Needles are disposable needles and should be discarded after each use. Store at room temperature in a dry cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Pens Needles are disposable needles and should be discarded after each use. Store at room temperature in a dry cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Pens Needles are disposable needles and should be discarded after each use. Store at room temperature in a dry cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Pens Needles are disposable needles and should be discarded after each use. Store at room temperature in a dry cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Pens Needles are disposable needles and should be discarded after each use. Store at room temperature in a dry cool place.

Device Identifiers

Device Issuing AgencyDevice ID
GS100850027494074 [Primary]
GS110850027494071 [Package]
Contains: 00850027494074
Package: Outer Carton [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 Date2021-04-01
Device Publish Date2021-03-24

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.