Primary Device ID | 30015482541997 |
NIH Device Record Key | d962d088-365e-44f9-85bf-448394a5b536 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | GLUCOCARD® Shine Blood Glucose Monitoring System |
Version Model Number | 541199 |
Company DUNS | 008171162 |
Company Name | ARKRAY USA, INC. |
Device Count | 1 |
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 | false |
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 | false |
Phone | +1(800)566-8558 |
xxx@xxx.xxx | |
Phone | +1(800)566-8558 |
xxx@xxx.xxx |
Special Storage Condition, Specify | Between 0 and 0 *Test Strips 34-86 F Meter 32-122 F |
Storage Environment Temperature | Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Test Strips 34-86 F Meter 32-122 F |
Storage Environment Temperature | Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Device Issuing Agency | Device ID |
---|---|
GS1 | 30015482541997 [Primary] |
CGA | GLUCOSE OXIDASE, GLUCOSE |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-09-23 |
50015482234237 - TechLITE PLUS PEN NEEDLES | 2024-03-19 Insulin Pen Needle. Intended for use with a pen injector device for the subcutaneous injection of insulin. |
10015482880160 - TechLITE® Lancets, 26g | 2023-10-05 TechLITE Lancets 26g 100's. The lancet is intended for capillary blood sampling. |
00015482880187 - TechLITE® Lancets, 28g | 2023-09-27 TechLITE Lancets 28g 100's. The lancet is intended for capillary blood sampling. |
10015482232297 - TechLITE PEN NEEDLES | 2023-09-08 Sterile, single-use pen needles. Intended for use with pen injector devices for the subcutaneous injection of drugs. |
10015482234321 - TechLITE PEN NEEDLES | 2023-09-08 Sterile, single-use pen needles. Intended for use with pen injector devices for the subcutaneous injection of drugs. |
10015482235311 - TechLITE PEN NEEDLES | 2023-09-08 Sterile, single-use pen needles. Intended for use with pen injector devices for the subcutaneous injection of drugs. |
10015482236325 - TechLITE PEN NEEDLES | 2023-09-08 Sterile, single-use pen needles. Intended for use with pen injector devices for the subcutaneous injection of drugs. |
10015482238312 - TechLITE PEN NEEDLES | 2023-09-08 Sterile, single-use pen needles. Intended for use with pen injector devices for the subcutaneous injection of drugs. |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
GLUCOCARD 79348263 not registered Live/Pending |
ARKRAY, Inc. 2022-04-22 |
GLUCOCARD 78885670 3499158 Live/Registered |
ARKRAY, Inc. 2006-05-17 |