FDA UDI
In Commercial Distribution
🇺🇸 United States
Philips FetView
DI: 00884838115958
·
Model: 795268
·
Philips Ultrasound, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Philips FetView
- Primary DI
- 00884838115958
- Version / Model
- 795268
- Company Name
- Philips Ultrasound, Inc.
- Labeler DUNS
- 063377717
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-23
- Public Version
- 2
- Public Version Date
- 2023-10-18
- Public Version Status
- Update
- Public Device Record Key
- 99cae629-e4cf-413b-b144-aabc4a1a8c90
Device Description
Submission for Philips FetView version 1.10.0 Initial release
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
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| LMD | System, Digital Image Communications, Radiological | Radiology | 892.2020 | 1 |
| OUG | Medical Device Data System | General Hospital | 880.6310 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41670 | Radiological PACS software | An individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00884838115958 | GS1 |