FDA.reportPublic FDA data

HEB In-Control Insulin Syringe

Primary DI
00041220791477
Brand
HEB In-Control Insulin Syringe
Company
H. E. BUTT GROCERY COMPANY
Model
79147
Catalog number
79147
Device description
"0.5mL 29G 1/2"" (12mm) Single use insulin syringe with needle. Includes 100 sterile syringes."
Published
2017-01-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K152879000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152879000Sure-Fine Insulin SyringesShina Med Corporation2016-09-09FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00041220791477PrimaryGS10
00041220791644Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00041220791477000412207914770412207914770041220791477
00041220791644000412207916440412207916440041220791644

GMDN Terms#

Term, Definition table
TermDefinition
Insulin syringe/needle, basicA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used to administer an injection of insulin to a patient subcutaneously; a non-retractable needle is included, either attached or detached (usually capped for user protection). The syringe is typically made of plastic and silicone materials and will have plunger anti-sticking properties allowing smooth plunger movement. It can be used by healthcare personnel or patient, and will allow for the aspiration of the pharmaceutical from its container for direct administration to the patient or via an intravenous (IV) port, heparin lock, or saline lock. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length12Millimeter
Needle Gauge29Gauge
Total Volume0.5Milliliter

Contacts#

Phone, Email table
PhoneEmail
1-800-886-1618info@allisonmedical.com

Regulatory Flags#

DUNS number
007924756
Device count
100
Lot or batch
true
Expiration date on label
true

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