True Comfort Insulin Syringes 31G 1/2CC 5/16" 1881

GUDID 10860000526552

(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 ID10860000526552
NIH Device Record Keyc64ad3d9-a4a1-4ae0-b936-28b794e24f09
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrue Comfort Insulin Syringes 31G 1/2CC 5/16"
Version Model NumberINS0531-0516
Catalog Number1881
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 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
GS100860000526555 [Primary]
GS110860000526552 [Package]
Contains: 00860000526555
Package: Case [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

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 Date2024-10-16
Device Publish Date2024-10-08

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