TechLITE Insulin Syringes 0.3mL 31G x 15/64" (6mm)

GUDID 10015482263147

TechLITe Insulin Syringe with fixed needle is a sterile single use syringe for the injection of U-100 insulin only.

ARKRAY USA, INC.

Insulin syringe/needle, basic

Primary Device ID	10015482263147
NIH Device Record Key	c83d280b-795f-423c-a1af-ec788d025802
Commercial Distribution Status	In Commercial Distribution
Brand Name	TechLITE Insulin Syringes 0.3mL 31G x 15/64" (6mm)
Version Model Number	260314
Company DUNS	008171162
Company Name	ARKRAY USA, INC.
Device Count	10
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	true

Customer Support Contacts

Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx

Device Dimensions

Total Volume	0.3 Milliliter
Length	6 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.3 Milliliter
Length	6 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.3 Milliliter
Length	6 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.3 Milliliter
Length	6 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.3 Milliliter
Length	6 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.3 Milliliter
Length	6 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.3 Milliliter
Length	6 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.3 Milliliter
Length	6 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.3 Milliliter
Length	6 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.3 Milliliter
Length	6 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.3 Milliliter
Length	6 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.3 Milliliter
Length	6 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.3 Milliliter
Length	6 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.3 Milliliter
Length	6 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.3 Milliliter
Length	6 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.3 Milliliter
Length	6 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.3 Milliliter
Length	6 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.3 Milliliter
Length	6 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.3 Milliliter
Length	6 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.3 Milliliter
Length	6 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.3 Milliliter
Length	6 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.3 Milliliter
Length	6 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.3 Milliliter
Length	6 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.3 Milliliter
Length	6 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.3 Milliliter
Length	6 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.3 Milliliter
Length	6 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.3 Milliliter
Length	6 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.3 Milliliter
Length	6 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.3 Milliliter
Length	6 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.3 Milliliter
Length	6 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.3 Milliliter
Length	6 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.3 Milliliter
Length	6 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.3 Milliliter
Length	6 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.3 Milliliter
Length	6 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.3 Milliliter
Length	6 Millimeter
Needle Gauge	31 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	00015482263140 [Package] Contains: 00015482613143 Package: Carton [10 Units] In Commercial Distribution
GS1	00015482613143 [Primary]
GS1	10015482263147 [Package] Contains: 00015482263140 Package: Master Shipper [10 Units] In Commercial Distribution
GS1	50015482613148 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K153537

FDA Product Code

FMF	Syringe, Piston

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2023-07-28
Device Publish Date	2018-01-09

Devices Manufactured by ARKRAY USA, INC.

00015482183103 - SPOTCHEM™ EZ Analyzer	2024-05-31 Dry Chemistry Analyzer IVD, semi-automated
00015482771010 - SPOTCHEM™ II Glucose	2024-05-31 Strip description for the invitro quantitative determination of glucose in human plasma from whole blood samples
00015482771027 - SPOTCHEM™ II Uric Acid	2024-05-31 Strip description for the invitro quantitative determination of uric acid concentration in human plasma from whole blood samples
00015482771034 - SPOTCHEM™ II Total Cholesterol	2024-05-31 Strip description for the invitro quantitative determination of total cholesterol in human plasma from whole blood samples
00015482771041 - SPOTCHEM™ II Triglycerides	2024-05-31 Strip is for invitro quantitative determination of triglycerides in human plasma from whole blood samples
00015482771058 - SPOTCHEM™ II BUN	2024-05-31 Strip description for the invitro quantitative determination of blood urea nitrogen in human plasma from whole blood samples
00015482771065 - SPOTCHEM™ II Total Bilirubin	2024-05-31 Strip description for the invitro quantitative determination of total bilirubin concentration in human plasma from whole blood s
00015482771072 - SPOTCHEM™ II Calcium	2024-05-31 Strip description for the invitro quantitative determination of calcium concentration in human plasma from whole blood samples