Commander Flex™
GUDID 00763000286972
HUB CD320 CMDR FLEX - GA
Medtronic Care Management Services, LLC
Multiple physiological parameter spot-check analysis system, home-use Multiple physiological parameter spot-check system, home-use Multiple physiological parameter spot-check system, home-use Multiple physiological parameter spot-check system, home-use Multiple physiological parameter spot-check system, home-use Multiple physiological parameter spot-check system, home-use Multiple physiological parameter spot-check system, home-use Multiple physiological parameter spot-check system, home-use Multiple physiological parameter spot-check system, home-use Multiple physiological parameter spot-check system, home-use Multiple physiological parameter spot-check system, home-use Multiple physiological parameter spot-check system, home-use Multiple physiological parameter spot-check system, home-use Multiple physiological parameter spot-check system, home-use Multiple physiological parameter spot-check system, home-use| Primary Device ID | 00763000286972 |
| NIH Device Record Key | 4682be36-8951-47ca-8d05-b2e7ab2f0a77 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Commander Flex™ |
| Version Model Number | 101001-001 |
| Company DUNS | 061079989 |
| Company Name | Medtronic Care Management Services, LLC |
| 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 | 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
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000286972 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K091821
FDA Product Code
| DXN | System, measurement, blood-pressure, non-invasive |
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 | 2019-07-16 |
| Device Publish Date | 2019-07-08 |
On-Brand Devices [Commander Flex™]
| 00763000001957 | HUB CD320 CMDR FLEX |
| 00763000286996 | HUB CD320 CMDR FLEX - CV |
| 00763000286989 | HUB CD320 CMDR FLEX - CA |
| 00763000286972 | HUB CD320 CMDR FLEX - GA |
Trademark Results [Commander Flex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 COMMANDER FLEX 85138725 4158470 Live/Registered |
MEDTRONIC CARE MANAGEMENT SERVICES, LLC 2010-09-27 |
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