FDA.report

Easy Comfort Pen Needles 8mm

Primary DI
00891237001706
Brand
Easy Comfort Pen Needles 8mm
Company
HOME AIDE DIAGNOSTICS, INC.
Model
I23108 or INSP31-8
Catalog number
1706
Device description
100ct box. 31G x 5/16 (8mm) Single use disposable pen needle for use with most insulin delivery systems. Includes 100 sterile needles individually wrapped.
Published
2016-05-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications

CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10891237001703PackageGS150In Commercial Distribution
00891237001706PrimaryGS10
20891237001700Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1089123700170310891237001703
00891237001706008912370017068912370017060891237001706
2089123700170020891237001700

GMDN Terms

TermDefinition
Hypodermic needle, single-useA non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.

Device Sizes

TypeValueUnit
Needle Gauge31Gauge

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Pens Needles are disposable needles and should be discarded after each use. Store at room temperature in a dry cool place.

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-915-0116info@homeaide.us

Regulatory Flags

DUNS number
783518983
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10850027494347True Comfort Knee Compression Wrap43402024-10-08
10850027494354Pure Comfort Leg Massager43572024-10-08
01085027494383Ultra Comfort Body Massager43882024-10-08
10850027494453Pro Health Track: Bluetooth Blood Pressure Monitor44562024-10-08
10850027494477Pro Comfort Lumbar Support44702024-10-08
10850027494484Ultra Comfort Heating Patch44872024-10-08
10850027494491Ultra Comfort Heated Socks44942024-10-08
10850027494521Total Comfort Elbow Support Sleeve LG45242024-10-08
10850027494538Total Comfort Knee Support Sleeve45242024-10-08
10850027494545Pro Comfort Safety Lancets 30G 100cnt45482024-10-08
10850027494590True Comfort Shoulder Compression Wrap45932024-10-08
10850027494651Easy Comfort Syringes 31G 5/16" 0.3CC46542024-10-08
10850027494668Easy Comfort Syringes 31G 1/2" 0.3CC46612024-10-08
10850027494972Easy Comfort Pro Insulin Syringes 31g 5/16” 1cc 40 count49752024-10-08
10850027494989Easy Comfort Pro Insulin Syringes 30g 5/16” 1cc 40 count49822024-10-08
10850058864003Easy Comfort Pro Insulin Syringes 30g 0.5in 1cc 40 count49992024-10-08
00850058864006True-Comfort Safety Pen Needles 4MM 32G12024-10-08
10850058864010True-Comfort Safety Pen Needles 5MM 31G22024-10-08
10850058864027True-Comfort Safety Pen Needles 6MM 31G12024-10-08
00850632007171Foot Comfort Ankle Gauntlet 71712024-10-08

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00850033131208RegenKit®-THT-1-URegenlab USA LLCFMI2026-03-23
40888277358455MEDLINEMEDLINE INDUSTRIES, INC.FMI2026-03-19
40888277358462MEDLINEMEDLINE INDUSTRIES, INC.FMI2026-03-19
10050428324070TRUEplusTRIVIDIA HEALTH, INC.FMI2026-03-17
16923033459243EZFINE THIN WALL HYPODERMIC NEEDLEZhejiang Kindly Medical Devices Co., Ltd.FMI2026-03-10
00850056748568FORWARD® Intraosseous Infusion BundleINTEGRATED MEDCRAFT LLCFMI2026-03-02
10850060997980CerosRhino Medical Supply IncFMI2026-02-23
08800062763736SHARP NEEDLES, DermiSyncYONG CHANG CorporationFMI2026-02-23
10857273002470Clickfine® pen needlesHTL STREFA S AFMI2026-02-17
10857273002487Clickfine® pen needlesHTL STREFA S AFMI2026-02-17
10857273002548Clickfine® pen needlesHTL STREFA S AFMI2026-02-17
10857273002555Clickfine® pen needlesHTL STREFA S AFMI2026-02-17
50192253037119MonojectCardinal Health 200, LLCFMI2026-02-17
20850083784052Comfort EZS.D.I. USA, INC.FMI2026-02-13
20850083784175Comfort EZS.D.I. USA, INC.FMI2026-02-13
04046955143184Omnican® fineB. Braun Melsungen AktiengesellschaftFMI2026-02-10
04046961013068Omnican® fineB. Braun Melsungen AktiengesellschaftFMI2026-02-10
50192253037010MonojectCardinal Health 200, LLCFMI2026-02-10
50192253037058MonojectCardinal Health 200, LLCFMI2026-02-10
50192253037096MonojectCardinal Health 200, LLCFMI2026-02-10
50192253037164MonojectCardinal Health 200, LLCFMI2026-02-10
50192253037171MonojectCardinal Health 200, LLCFMI2026-02-10
50192253037218MonojectCardinal Health 200, LLCFMI2026-02-10
50192253038154MonojectCardinal Health 200, LLCFMI2026-02-10
50192253038161MonojectCardinal Health 200, LLCFMI2026-02-10
50192253038178MonojectCardinal Health 200, LLCFMI2026-02-10
50192253038185MonojectCardinal Health 200, LLCFMI2026-02-10
50192253038192MonojectCardinal Health 200, LLCFMI2026-02-10
50192253038208MonojectCardinal Health 200, LLCFMI2026-02-10
50192253038215MonojectCardinal Health 200, LLCFMI2026-02-10