FDA UDI
In Commercial Distribution
🇺🇸 United States
Prometra Programmable Pump
DI: 00810335020242
·
Model: 16827
·
Flowonix Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Prometra Programmable Pump
- Primary DI
- 00810335020242
- Version / Model
- 16827
- Company Name
- Flowonix Medical, Inc.
- Labeler DUNS
- 013518517
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-05
- Public Version
- 1
- Public Version Date
- 2020-06-15
- Public Version Status
- New
- Public Device Record Key
- dd6d66c4-9a5f-4a8d-bb77-28547ce07c58
Device Description
Prometra II 40ml Programmable Pump
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LKK | Pump, Infusion, Implanted, Programmable | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46024 | Implantable intrathecal infusion pump, programmable | A battery-powered, programmable, sterile device designed to be implanted in a patient for the storing and subarachnoid (intrathecal) administration of narcotics/drugs (e.g., morphine sulfate, baclofen) to manage intractable pain and muscle spasms of malignant or non-malignant origin. This implantable infusion pump (IIP) delivers drug doses from its implanted reservoir which is controlled by drug concentration and/or by radio-frequency (RF) signals from an external programming device. The drug reservoir, usually implanted under the skin of the lower abdomen, is typically connected to a catheter placed into the spinal fluid space. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810335020242 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P080012 | 049 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 52 Degrees Celsius