AgaMatrix
GUDID 20385544940017
System Kit, Blood Glucose Meter, AgaMatrix, Presto (Pillow), mg/dL
AGAMATRIX, INC.
Glucose monitoring system IVD, home-use| Primary Device ID | 20385544940017 |
| NIH Device Record Key | 0533ca20-400e-45c1-921e-b5ed8d95ff9c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AgaMatrix |
| Version Model Number | 8000-04940 |
| Company DUNS | 156756129 |
| Company Name | AGAMATRIX, 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 | true |
| 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 | 1-866-906-4197 |
| customerservice@agamatrix.com | |
| Phone | 1-866-906-4197 |
| customerservice@agamatrix.com | |
| Phone | 1-866-906-4197 |
| customerservice@agamatrix.com | |
| Phone | 1-866-906-4197 |
| customerservice@agamatrix.com | |
| Phone | 1-866-906-4197 |
| customerservice@agamatrix.com | |
| Phone | 1-866-906-4197 |
| customerservice@agamatrix.com | |
| Phone | 1-866-906-4197 |
| customerservice@agamatrix.com | |
| Phone | 1-866-906-4197 |
| customerservice@agamatrix.com | |
| Phone | 1-866-906-4197 |
| customerservice@agamatrix.com | |
| Phone | 1-866-906-4197 |
| customerservice@agamatrix.com | |
| Phone | 1-866-906-4197 |
| customerservice@agamatrix.com | |
| Phone | 1-866-906-4197 |
| customerservice@agamatrix.com | |
| Phone | 1-866-906-4197 |
| customerservice@agamatrix.com | |
| Phone | 1-866-906-4197 |
| customerservice@agamatrix.com | |
| Phone | 1-866-906-4197 |
| customerservice@agamatrix.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00385544940013 [Primary] |
| GS1 | 20385544940017 [Package] Contains: 00385544940013 Package: Shipper [12 Units] In Commercial Distribution |
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 | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-12-03 |
| Device Publish Date | 2016-11-04 |
On-Brand Devices [AgaMatrix]
| 20385544940017 | System Kit, Blood Glucose Meter, AgaMatrix, Presto (Pillow), mg/dL |
| 00385544025017 | System Kit, Blood Glucose Meter, Agamatrix, AMP, mg/dL |
| 20385543764027 | Control Solution, AgaMatrix, Combo Normal and High |
| 20385542649011 | System Kit, Blood Glucose Meter, AgaMatrix, Presto, mg/dL |
| 10385541002605 | System Kit, Blood Glucse Meter, AgaMatrix, Jazz Wireless 2, mg/dL |
| 00385541002509 | Blood Glucse Meter, AgaMatrix, Jazz Wireless 2, mg/dL |
| 10385541002407 | Test Strips, AgaMatrix, Jazz, 50CT |
| 10385541002001 | Test Strips, AgaMatrix, Jazz, 10CT |
| 20385541000806 | System Kit, Blood Glucse Meter, Agamatrix, Presto PRO, mg/dL |
| 10385542661016 | Blood Glucose Meter, AgaMatrix, Presto, mg/dL |
| 10385541000700 | Blood Glucse Meter, Agamatrix, Presto PRO, mg/dL |
| 10385544063016 | Blood Glucose Meter, Agamatrix, AMP, mg/dL |
| 30385544036014 | Test Strips, AgaMatrix, AMP, 50CT |
| 10385543909018 | Blood Glucose Meter, AgaMatrix, Presto (Pillow), mg/dL |
| 30385543337013 | Test Strips, AgaMatrix, Presto, 50CT |
| 20385542011016 | Control Solution, AgaMatrix, High |
| 10385541335017 | Control Solution, AgaMatrix, Normal |
| 20385541003401 | Control Solution, AgaMatrix, Level 4 |
| 20385541003203 | Control Solution, AgaMatrix, Level 2 |
| 30385541001602 | Test Strips, AgaMatrix, Presto, 10CT |
| 20385541971014 | Lancets, AgaMatrix, 100CT, 33Gauge |
| 20385541833015 | Lancets, AgaMatrix, 100CT, 28Gauge |
Trademark Results [AgaMatrix]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AGAMATRIX 85314199 4226717 Live/Registered |
AgaMatrix, Inc. 2011-05-06 |
 AGAMATRIX 78374141 3412624 Live/Registered |
AgaMatrix, Inc. 2004-02-25 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.