FDA UDI
In Commercial Distribution
🇺🇸 United States
Extravasation Detection Patch with Access Slot
DI: 17630039300347
·
Model: 017352
·
Bracco Injeneering SA
Product Codes
3
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Extravasation Detection Patch with Access Slot
- Primary DI
- 17630039300347
- Version / Model
- 017352
- Catalog Number
- 017352
- Company Name
- Bracco Injeneering SA
- Labeler DUNS
- 482489007
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-20
- Public Version
- 5
- Public Version Date
- 2024-01-03
- Public Version Status
- Update
- Public Device Record Key
- aa247bbd-cb8e-4e54-b256-d896639fde61
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| DSB | Plethysmograph, Impedance | Cardiovascular | 870.2770 | 2 |
| JAK | System, X-Ray, Tomography, Computed | Radiology | 892.1750 | 2 |
| IZQ | Injector, Contrast Medium, Automatic | Cardiovascular | 870.1650 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60474 | Neoplasm electrical impedance spectrometer electrode array | An arrangement of multiple electrical conductors intended to be used in conjunction with an electrical impedance (bioimpedance) spectrometer (EIS/BIS) to apply a small electric current to the skin during EIS analysis, typically of neoplastic skin. It is typically a small cover that fits over a probe and may be textured (e.g., with pins) to penetrate the outermost layer of skin. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 17630039300347 | GS1 | ||||
| Package | 27630039300344 | GS1 | Box | 25 | In Commercial Distribution | |
| Package | 37630039300341 | GS1 | Box | 50 | In Commercial Distribution |
Customer Contacts
- Phone
- +41216236030
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Dry Environment