FDA UDI
In Commercial Distribution
🇺🇸 United States
Commander Flex™
DI: 00763000286989
·
Model: 101001-002
·
Medtronic Care Management Services, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Commander Flex™
- Primary DI
- 00763000286989
- Version / Model
- 101001-002
- Company Name
- Medtronic Care Management Services, LLC
- Labeler DUNS
- 061079989
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-08
- Public Version
- 3
- Public Version Date
- 2022-10-10
- Public Version Status
- Update
- Public Device Record Key
- 8abb1bfb-952a-42f0-8362-e2caf395438e
Device Description
HUB CD320 CMDR FLEX - CA
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DXN | System, measurement, blood-pressure, non-invasive | Cardiovascular | 870.1130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48041 | Multiple physiological parameter spot-check system, home-use | An electrically-powered device assembly designed for use in the home to spot-check (user-initiated) measure and display multiple patient physiological parameters [e.g., blood pressure, blood glucose, pulse rate, temperature, haemoglobin oxygen saturation (SpO2), and possibly calculate mean arterial pressure (MAP)]. It typically includes a main unit with a visual display intended to process/store the data, and physiological measuring components (e.g., thermometer, blood pressure cuff, blood glucose meter); it may additionally allow the data to be communicated with a healthcare professional. It may be used in a healthcare facility and in the home. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00763000286989 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K091821 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -4 – 131 Degrees Fahrenheit