FDA.reportPublic FDA data

True-Comfort Safety Pen Needles 5MM 31G

Primary DI
10850058864010
Brand
True-Comfort Safety Pen Needles 5MM 31G
Company
HOME AIDE DIAGNOSTICS, INC.
Model
2
Device description
Safety Pen Needles 5MM 31G
Published
2024-10-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192677000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192677000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850058864010PackageGS120In Commercial Distribution
00850058864013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085005886401010850058864010
00850058864013008500588640138500588640130850058864013

GMDN Terms#

Term, Definition table
TermDefinition
Subcutaneous infusion/injection port needleA sterile, sharp bevel-edged, hollow tubular metal instrument intended to be attached to a syringe and designed for the therapeutic injection or infusion of medicinal substances directly beneath the skin layer. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length5Millimeter
Needle Gauge31Gauge

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity40 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-915-0116info@homeaide.us

Regulatory Flags#

DUNS number
783518983
Device count
1
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860015635518Ultra-Care Disposable Safety Lancets 30GUCSLAN2026-05-05
00850071765069Easy Comfort Safety Lancets 30G 100cntECSLAN2026-05-01
00891237001195Easy Step Blood Glucose Test Strips 50ctT5D2-0011952016-05-03
00891237001423Easy Trak Blood Glucose Test Strips 25ct20002004914232016-05-03
00891237001485Easy Talk Blood Glucose Testing Strips 25ct881814852016-05-03
00891237001645Easy Plus II Blood Glucose Testing Strips 25ct881816452016-05-03
00850027494654"Easy Comfort Syringes 31G 5/16"" 0.3CC"46542024-10-08
00850027494661"Easy Comfort Syringes 31G 1/2"" 0.3CC"46612024-10-08
00850027494975Easy Comfort Pro Insulin Syringes 31g 5/16” 1cc 40 count49752024-10-08
00850027494982Easy Comfort Pro Insulin Syringes 30g 5/16” 1cc 40 count49822024-10-08
00850027494999Easy Comfort Pro Insulin Syringes 30g 0.5in 1cc 40 count49992024-10-08
00891237001034Comfort Heal Heating PadJY610110342018-02-14
00850027494517Smart Neb Pediatric NebulizerSNebPN2023-11-03
00850632007225Easy NebMCN-S600MB72252018-01-26
00850632007553Pure Air Mini NebulizerMCN-S600A2020-03-24
00891237001607Easy Air Compressor NebulizerMCN-S600MC16072016-05-01
00850058864082Easy Comfort 3L Sharps Container {3.17 Quarts}SC3L2024-06-14
00850027494340True Comfort Knee Compression Wrap43402024-10-08
00850027494357Pure Comfort Leg Massager43572024-10-08
00850027494388Ultra Comfort Body Massager43882024-10-08

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