True Comfort Pro Insulin Syringes 31G 1/2CC 5/16"

GUDID 10850027494101

(1/2cc)(5/16")(31G) Single use disposable insulin syringes. Includes 100 sterile needles individually wrapped.

HOME AIDE DIAGNOSTICS, INC.

Metered-delivery hypodermic syringe
Primary Device ID10850027494101
NIH Device Record Key4271f32d-eb5b-4396-86cc-93c606300560
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrue Comfort Pro Insulin Syringes 31G 1/2CC 5/16"
Version Model NumberINS0531-0516
Company DUNS783518983
Company NameHOME AIDE DIAGNOSTICS, INC.
Device Count100
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 Gauge31 Gauge
Device Size Text, specify0
Length0.3125 Inch
Needle Gauge31 Gauge
Device Size Text, specify0
Length0.3125 Inch
Needle Gauge31 Gauge
Device Size Text, specify0
Length0.3125 Inch
Needle Gauge31 Gauge
Device Size Text, specify0
Length0.3125 Inch
Needle Gauge31 Gauge
Device Size Text, specify0
Length0.3125 Inch
Needle Gauge31 Gauge
Device Size Text, specify0
Length0.3125 Inch
Needle Gauge31 Gauge
Device Size Text, specify0
Length0.3125 Inch
Needle Gauge31 Gauge
Device Size Text, specify0
Length0.3125 Inch
Needle Gauge31 Gauge
Device Size Text, specify0
Length0.3125 Inch
Needle Gauge31 Gauge
Device Size Text, specify0
Length0.3125 Inch
Needle Gauge31 Gauge
Device Size Text, specify0
Length0.3125 Inch
Needle Gauge31 Gauge
Device Size Text, specify0
Length0.3125 Inch
Needle Gauge31 Gauge
Device Size Text, specify0
Length0.3125 Inch
Needle Gauge31 Gauge
Device Size Text, specify0
Length0.3125 Inch
Needle Gauge31 Gauge
Device Size Text, specify0
Length0.3125 Inch
Needle Gauge31 Gauge
Device Size Text, specify0
Length0.3125 Inch
Needle Gauge31 Gauge
Device Size Text, specify0
Length0.3125 Inch

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Insulin Syringes 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 *Insulin Syringes 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 *Insulin Syringes 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 *Insulin Syringes 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 *Insulin Syringes 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 *Insulin Syringes 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 *Insulin Syringes 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 *Insulin Syringes 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 *Insulin Syringes 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 *Insulin Syringes 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 *Insulin Syringes 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 *Insulin Syringes 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 *Insulin Syringes 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 *Insulin Syringes 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 *Insulin Syringes 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 *Insulin Syringes 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 *Insulin Syringes 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
GS100850027494104 [Primary]
GS110850027494101 [Package]
Contains: 00850027494104
Package: Outer Carton [20 Units]
In Commercial Distribution
GS120850027494108 [Unit of Use]

FDA Product Code

FMFSyringe, Piston

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.