FDA.reportPublic FDA data

Pro Comfort Insulin Syringes (1/2cc)(1/2")(30G)

Primary DI
10850632007086
Brand
Pro Comfort Insulin Syringes (1/2cc)(1/2")(30G)
Company
HOME AIDE DIAGNOSTICS, INC.
Model
INS0530-0102
Catalog number
7089
Device description
(1/2cc)(1/2")(30G) Single use disposable insulin syringes. Includes 100 sterile needles individually wrapped.
Published
2016-07-15
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850632007086PackageGS120In Commercial Distribution
00850632007089PrimaryGS10
20850632007083Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085063200708610850632007086
00850632007089008506320070898506320070890850632007089
2085063200708320850632007083

GMDN Terms#

Term, Definition table
TermDefinition
Metered-delivery hypodermic syringeA sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0.5Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Insulin Syringes are disposable needles and should be discarded after each use. Store at room temperature in a dry cool place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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 DI, Brand, Model table
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

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