FDA.report

Easy Comfort Insulin Syringes (1cc)(5/16")(31G)

Primary DI
00891237001898
Brand
Easy Comfort Insulin Syringes (1cc)(5/16")(31G)
Company
HOME AIDE DIAGNOSTICS, INC.
Model
INS0131-0516
Catalog number
1898
Device description
(1cc)(5/16")(31G) Single use disposable insulin syringes. 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
FMFSyringe, Piston

Product Code Classifications

CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10891237001895PackageGS120In Commercial Distribution
00891237001898PrimaryGS10
20891237001892Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1089123700189510891237001895
00891237001898008912370018988912370018980891237001898
2089123700189220891237001892

GMDN Terms

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

TypeValueUnit
Needle Gauge31Gauge

Storage And Handling

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

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

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