FDA UDI
Not in Commercial Distribution
🇺🇸 United States
CABLE,FIBER OPTIC VCG
DI: 00884838032507
·
Model: 452215033602
·
Philips Ds North America LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CABLE,FIBER OPTIC VCG
- Primary DI
- 00884838032507
- Version / Model
- 452215033602
- Catalog Number
- 452215033602
- Company Name
- Philips Ds North America LLC
- Labeler DUNS
- 013649151
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-04-22
- Public Version
- 4
- Public Version Date
- 2024-02-01
- Public Version Status
- Update
- Public Device Record Key
- f37f4c67-e20c-405e-b330-8b57ca2c0e8f
- Distribution End Date
- 2019-09-15
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- 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 |
|---|---|---|---|---|
| MWI | Monitor, physiological, patient (without arrhythmia detection or alarms) | Cardiovascular | 870.2300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36005 | MRI system synchronizer | A physiological monitoring unit used as a component of a diagnostic magnetic resonance imaging (MRI) system, that produces a signal which enables image formation or data collection to be synchronized with a specific measurable physiological parameter, e.g., the beginning of a patient's respiratory or cardiac cycle. It is primarily used for the purpose of artifact reduction or enhancement of signal-to-noise ratios in various real-time or dynamic MRI applications. It is sometimes referred to as a gated imaging accessory or trigger. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00884838032507 | GS1 |
Customer Contacts
- Phone
- +1(999)999-9999
- [email protected]