"TechLITE Insulin Syringes 0.3mL 29G x 1/2"" (12mm)"

Primary DI
00015482612917
Brand
"TechLITE Insulin Syringes 0.3mL 29G x 1/2"" (12mm)"
Company
ARKRAY USA, INC.
Model
260291
Device description
TechLITe Insulin Syringe with fixed needle is a sterile single use syringe for the injection of U-100 insulin only.
Published
2018-01-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153537000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153537000Sol-M Insulin Syringe, Sol-M TB SyringeSol-Millennium Medical, Inc.2016-06-17FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00015482262914PackageGS110In Commercial Distribution
10015482262911PackageGS110In Commercial Distribution
00015482612917PrimaryGS10
50015482612912Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00015482262914000154822629140154822629140015482262914
1001548226291110015482262911
00015482612917000154826129170154826129170015482612917
5001548261291250015482612912

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 Volume0.3Milliliter

Contacts#

Phone, Email table
PhoneEmail
1-800-818-8877xxx@xxx.xxx

Regulatory Flags#

DUNS number
008171162
Device count
10
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Model table
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00015482600501Assure® Titanium Blood Glucose Test Strips6000502025-09-15
00015482601003Assure® Titanium Blood Glucose Test Strips6001002025-09-15
00015482600013Assure® Titanium Blood Glucose Meter6000012025-09-15
10015482600508Assure® Titanium Blood Glucose Test Strips6000502025-09-15
10015482601000Assure® Titanium Blood Glucose Test Strips6001002025-09-15
00015482510046Assure® Control - Control Solution Level 15100042019-04-01
00015482510053Assure® Control - Control Solution Level 25100052019-04-01
00015482510077Assure® Control - Control Solution Level 35100072019-04-01
00015482102913ASSURE® ID Insulin 1cc Safety Syringe2102912016-09-23
00015482102951ASSURE® ID Insulin 0.5cc Safety Syringe2102952016-09-23
00015482511104GLUCOCARD® W Blood Glucose Monitoring System 5111002019-04-01
00015482512057GLUCOCARD® W Blood Glucose Test Strips5120502019-04-01
10015482102910ASSURE® ID Insulin 1cc Safety Syringe2102912016-09-23
10015482102958ASSURE® ID Insulin 0.5cc Safety Syringe2102952016-09-23
30015482501779Assure® Platinum Blood Glucose Meter5011772022-06-17

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