Redleaf

Primary DI
00850060163128
Brand
Redleaf
Company
Elimedical-Us LLC
Model
10K2713
Device description
RedLeaf Insulin Syringe 1cc, 27g x 1/2 inch, 100 per box, 10K2713
Published
2024-02-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112057000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112057000KDL SYRINGES AND NEEDLEShanghai Kindly Enterprise Dev. Group Co.,2011-12-14FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20850060163122PackageGS112Not in Commercial Distribution
00850060163128PrimaryGS10
10850060163125Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085006016312220850060163122
00850060163128008500601631288500601631280850060163128
1085006016312510850060163125

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
Length0.5Inch
Needle Gauge27Gauge
Total Volume1Milliliter

Contacts#

Phone, Email table
PhoneEmail
609-968-0461tony@elimedical.com

Regulatory Flags#

DUNS number
105596255
Device count
100
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850060163043Redleaf03K31082024-02-29
00850060163111Redleaf05K31082024-02-29
00850060163142Redleaf10K29132024-02-29
00850060163180Redleaf10K31082024-02-29
20850060163047Redleaf03K31082024-02-29
20850060163115Redleaf05K31082024-02-29
20850060163122Redleaf10K27132024-02-29
20850060163146Redleaf10K29132024-02-29
20850060163184Redleaf10K31082024-02-29

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Primary DI, Brand, Company table
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