FDA UDI
In Commercial Distribution
🇺🇸 United States
Pure Vue
DI: 10886705032204
·
Model: 242329
·
Medos International Sàrl
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Pure Vue
- Primary DI
- 10886705032204
- Version / Model
- 242329
- Catalog Number
- 242329
- Company Name
- Medos International Sàrl
- Labeler DUNS
- 482661753
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-27
- Public Version
- 1
- Public Version Date
- 2021-06-04
- Public Version Status
- New
- Public Device Record Key
- a1ec76f4-2d28-4c98-beda-285170f7c2df
Device Description
Pure Vue Software expansion
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
- 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 |
|---|---|---|---|---|
| FCW | Light source, fiberoptic, routine | Gastroenterology, Urology | 876.1500 | 2 |
| GCJ | Laparoscope, general & plastic surgery | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58474 | Software upgrade/unlocking key | A software, hardware, or software/hardware combination device intended to be used to update/upgrade/unlock software embedded on a medical device through the use of an integral or separate media device (e.g., USB flash drive, CD). If supplied on a dedicated USB drive, it may be otherwise known as a ‘dongle’. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10886705032204 | GS1 |
Customer Contacts
- Phone
- +1(800)255-2500
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 38 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- -20 – 38 Degrees Celsius