FDA UDI
In Commercial Distribution
🇺🇸 United States
Prometra Programmer
DI: 00810335020129
·
Model: 11828
·
Flowonix Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Prometra Programmer
- Primary DI
- 00810335020129
- Version / Model
- 11828
- Company Name
- Flowonix Medical, Inc.
- Labeler DUNS
- 013518517
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-24
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 623afc38-49b9-437c-9bea-4da9b8cd7576
Device Description
The Prometra Programmer is a non-sterile handheld menu driven device, external to the implanted pump that enables remote programming of the Prometra pump.
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
- Yes
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| LKK | Pump, Infusion, Implanted, Programmable | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44074 | Infusion pump programmer | An external device that enables a user to interrogate, test, analyse and program, noninvasively, one or more of the operating parameters (the programs) of an implanted infusion pump. It is able to read stored parameters in the infusion pump, providing historic and/or current information regarding performance, and may be used to upload new software into the infusion pump. It is a dedicated device, typically with an electronic wand with a communication antenna, connected to a port of a personal computer (PC) using dedicated software to drive the electronics of the wand to communicate with the implanted infusion pump. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810335020129 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P080012 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not get wet