FDA.reportPublic FDA data

TechLITE Insulin Syringes 1mL 30G x 1/2" (12mm)

Primary DI
10015482263055
Brand
TechLITE Insulin Syringes 1mL 30G x 1/2" (12mm)
Company
ARKRAY USA, INC.
Model
260305
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
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

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
00015482263058PackageGS110In Commercial Distribution
10015482263055PackageGS110In Commercial Distribution
00015482613051PrimaryGS10
50015482613056Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00015482263058000154822630580154822630580015482263058
1001548226305510015482263055
00015482613051000154826130510154826130510015482613051
5001548261305650015482613056

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length12Millimeter
Needle Gauge30Gauge
Total Volume1Milliliter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
008171162
Device count
10
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
false
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
00015482000011ARK Care®Version 2.5.3.2016-09-23
00015482100025Assure® Slide Pill Swallowing Aid forte10000022018-12-28
00015482100032Assure® Slide Pill Swallowing Aid zero10000032018-12-28
00015482102913ASSURE® ID Insulin 1cc Safety Syringe2102912016-09-23
00015482102951ASSURE® ID Insulin 0.5cc Safety Syringe2102952016-09-23
00015482104658AUTION MAX™ AX-4060 Analyzer1005262025-11-07
00015482129743AUTION™ MAX AX-4022 Analyzer1029742017-02-03
00015482230296TechLITE PEN NEEDLES2301292016-09-23
00015482230326TechLITE Pen Needle 4mm x 32g Sample 10's2340322018-02-26
00015482230999TechLITE PEN NEEDLES2309292016-09-23
00015482232290TechLITE PEN NEEDLES2321292016-09-23
00015482232993TechLITE PEN NEEDLES2329292016-09-23
00015482234232TechLITE PLUS PEN NEEDLES2342322024-03-11
00015482234324TechLITE PEN NEEDLES2341322016-09-23
00015482234928TechLITE PEN NEEDLES2349322016-09-23
00015482235314TechLITE PEN NEEDLES2351312019-05-14
00015482235918TechLITE PEN NEEDLES2359312016-09-23
00015482236311TechLITE PEN NEEDLES2361312016-09-23
00015482236328TechLITE PEN NEEDLES2361322016-09-23
00015482238315TechLITE PEN NEEDLES2381312016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850083045425EasytoUse U-100 Insulin SyringeOneTouch Medical, LLCFMF2026-11-03
00850083045456EasytoUse U-100 Insulin SyringeOneTouch Medical, LLCFMF2026-11-03
00850083045555EasytoUse U-100 Insulin SyringeOneTouch Medical, LLCFMF2026-11-03
00850083045623EasytoUse U-100 Insulin SyringeOneTouch Medical, LLCFMF2026-11-03
00850083045654EasytoUse U-100 Insulin SyringeOneTouch Medical, LLCFMF2026-11-03
00850083045722EasytoUse U-100 Insulin SyringeOneTouch Medical, LLCFMF2026-11-03
00850083045753EasytoUse U-100 Insulin SyringeOneTouch Medical, LLCFMF2026-11-03
00850083045821EasytoUse U-100 Insulin SyringeOneTouch Medical, LLCFMF2026-11-03
00850083045852EasytoUse U-100 Insulin SyringeOneTouch Medical, LLCFMF2026-11-03
00840216124387LiteTouchAsp Global, LLCFMF2026-11-02
00840216124424LiteTouchAsp Global, LLCFMF2026-11-02
00840216124448LiteTouchAsp Global, LLCFMF2026-11-02
00840216124462LiteTouchAsp Global, LLCFMF2026-11-02
00840216123779LiteTouchAsp Global, LLCFMF2026-10-30
00840216123809LiteTouchAsp Global, LLCFMF2026-10-30
00840216123960LiteTouchAsp Global, LLCFMF2026-10-30
00840216123984LiteTouchAsp Global, LLCFMF2026-10-30
00840216124004LiteTouchAsp Global, LLCFMF2026-10-30
00840216124028LiteTouchAsp Global, LLCFMF2026-10-30
00840216124301LiteTouchAsp Global, LLCFMF2026-10-30
00840216124363LiteTouchAsp Global, LLCFMF2026-10-30
06934841531291TKMDAnhui Tiankang Medical Technology Co., Ltd.FMF2026-10-23
MHC182332552EasyTouchMHC MEDICAL PRODUCTS, LLCFMF2026-10-21
09347144013062Metier MedicalMETIER MEDICAL LTDFMF2026-10-19
09347144013123Metier MedicalMETIER MEDICAL LTDFMF2026-10-19
09347144015004Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
09347144016186Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
09347144016216Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
00850091070532CoreCareCorecare Products Inc.FMF2026-09-11
00850091070556CoreCareCorecare Products Inc.FMF2026-09-11