FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 10886704064947
·
Model: 91-4205US
·
Medos International Sàrl
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 10886704064947
- Version / Model
- 91-4205US
- Catalog Number
- 914205US
- Company Name
- Medos International Sàrl
- Labeler DUNS
- 482661753
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-20
- Public Version
- 4
- Public Version Date
- 2022-02-08
- Public Version Status
- Update
- Public Device Record Key
- 443702ca-daad-4eaf-a892-9c522bbe870e
- Distribution End Date
- 2024-12-31
Device Description
Control Unit Includes: Control Unit;Hardware Key;Carrying Case Keys 2 ; Adapters 3; Battery Charger; USB Cable;Information Manuals and Carrying Case
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
- Yes
- 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 | 10886704064947 | GS1 | ||||
| Direct Marking | 10886704071426 | GS1 |
Customer Contacts
- Phone
- +1(800)255-2500
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 41 – 86 Degrees Fahrenheit
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 85 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 30 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 30 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 85 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 41 – 86 Degrees Fahrenheit