SMARTMETER
GUDID 00883489002525
kit only has one meter
BIONIME CORPORATION
Glucose monitoring system IVD, home-use| Primary Device ID | 00883489002525 |
| NIH Device Record Key | d7df5dfd-e2c9-4571-a533-3b4e00759184 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SMARTMETER |
| Version Model Number | GM291 |
| Company DUNS | 658637244 |
| Company Name | BIONIME CORPORATION |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| 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 | 1-8444458267 |
| support@iglucose.com | |
| Phone | 1-8444458267 |
| support@iglucose.com | |
| Phone | 1-8444458267 |
| support@iglucose.com | |
| Phone | 1-8444458267 |
| support@iglucose.com | |
| Phone | 1-8444458267 |
| support@iglucose.com | |
| Phone | 1-8444458267 |
| support@iglucose.com | |
| Phone | 1-8444458267 |
| support@iglucose.com | |
| Phone | 1-8444458267 |
| support@iglucose.com | |
| Phone | 1-8444458267 |
| support@iglucose.com | |
| Phone | 1-8444458267 |
| support@iglucose.com | |
| Phone | 1-8444458267 |
| support@iglucose.com | |
| Phone | 1-8444458267 |
| support@iglucose.com | |
| Phone | 1-8444458267 |
| support@iglucose.com | |
| Phone | 1-8444458267 |
| support@iglucose.com | |
| Phone | 1-8444458267 |
| support@iglucose.com | |
| Phone | 1-8444458267 |
| support@iglucose.com | |
| Phone | 1-8444458267 |
| support@iglucose.com |
Operating and Storage Conditions
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00883489002518 [Primary] |
| GS1 | 00883489002525 [Package] Contains: 00883489002518 Package: box [1 Units] In Commercial Distribution |
| GS1 | 10883489002522 [Package] Package: box [10 Units] In Commercial Distribution |
| GS1 | 20883489002529 [Package] Contains: 10883489002522 Package: BOX [4 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K161790
FDA Product Code
| NBW | System, Test, Blood Glucose, Over The Counter |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-01-26 |
| Device Publish Date | 2024-01-18 |
On-Brand Devices [SMARTMETER]
| 00883489002501 | Control Solution-Level 2 |
| 00883489002525 | kit only has one meter |
Trademark Results [SMARTMETER]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SMARTMETER 76343875 2607579 Live/Registered |
Gardner Denver, Inc. 2001-11-30 |
 SMARTMETER 76133818 not registered Dead/Abandoned |
Penn, Laurence Richard 2000-09-22 |
 SMARTMETER 76099167 not registered Dead/Abandoned |
Innovapark LLC 2000-07-28 |
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