Guardian™ Connect
GUDID 00763000388379
KIT ASSY PKG MMT-7821LNA INTRICON US
MEDTRONIC MINIMED, INC.
Percutaneous interstitial-fluid glucose monitoring system| Primary Device ID | 00763000388379 |
| NIH Device Record Key | 29c29a0a-ff1f-4b55-b9f1-7190eeafe3a7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Guardian™ Connect |
| Version Model Number | MMT-7821LNA |
| Company DUNS | 849626338 |
| Company Name | MEDTRONIC MINIMED, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000388379 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
FDA Product Code
| MDS | Sensor, glucose, invasive |
| OZP | Automated insulin dosing device system, single hormonal control |
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 | 2020-11-03 |
| Device Publish Date | 2020-10-26 |
On-Brand Devices [Guardian™ Connect]
| 00763000002602 | STARTER KIT MMT-7820LNA GST4C LOCKOUT US |
| 00763000002596 | XMTR MMT-7821LNA GST4C LOCKOUT US |
| 00763000285852 | KIT MMT-7820PNA XMTR LOCKOUT GST4C RX |
| 00763000398330 | RPL MMT-7821LNA GST4C LOCKOUT EN CD |
| 00763000399009 | KIT MMT-7820LNA GST4C LOCKOUT CD |
| 00763000408893 | STARTER KIT MMT-7820PNA GST4C 4.1 RX |
| 00763000408886 | STARTER KIT MMT-7820LNA GST4C 4.1 |
| 00763000388379 | KIT ASSY PKG MMT-7821LNA INTRICON US |
| 00763000388355 | KIT ASSY PKG MMT-7820LNA INTRICON US |
Trademark Results [Guardian]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GUARDIAN 98890042 not registered Live/Pending |
Unirac, Inc. 2024-12-06 |
 GUARDIAN 98858933 not registered Live/Pending |
Medline Industries, LP 2024-11-18 |
 GUARDIAN 98858767 not registered Live/Pending |
Medline Industries, LP 2024-11-18 |
 GUARDIAN 98694879 not registered Live/Pending |
Guardian Products, LLC 2024-08-12 |
 GUARDIAN 98674622 not registered Live/Pending |
Starrily, Inc. 2024-07-30 |
 GUARDIAN 98634266 not registered Live/Pending |
Proven PCI, Inc. 2024-07-05 |
 GUARDIAN 98615281 not registered Live/Pending |
Syscend, Inc. 2024-06-24 |
 GUARDIAN 98589070 not registered Live/Pending |
Zero Zone, Inc. 2024-06-06 |
 GUARDIAN 98543933 not registered Live/Pending |
Guardian Innovations LLC 2024-05-10 |
 GUARDIAN 98543925 not registered Live/Pending |
Guardian Innovations LLC 2024-05-10 |
 GUARDIAN 98516659 not registered Live/Pending |
National Oilwell Varco, L.P. 2024-04-24 |
 GUARDIAN 98499919 not registered Live/Pending |
MirOil USA, LLC 2024-04-15 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.