FDA UDI
In Commercial Distribution
🇺🇸 United States
Internal Battery PM Upgrade USB Drive
DI: 00850018761451
·
Model: PRT-01907-000
·
Ventec Life Systems, Inc.
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Internal Battery PM Upgrade USB Drive
- Primary DI
- 00850018761451
- Version / Model
- PRT-01907-000
- Catalog Number
- PRT-01907-000
- Company Name
- Ventec Life Systems, Inc.
- Labeler DUNS
- 078758082
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-02
- Public Version
- 1
- Public Version Date
- 2025-12-10
- Public Version Status
- New
- Public Device Record Key
- ede19bf3-929b-4b13-9ab7-f17833df7da0
Device Description
Eaches- Internal Battery PM Upgrade USB Drive, PRT-01907-000 - 00850018761451
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
- Yes
- 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 |
|---|---|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | Anesthesiology | 868.5895 | 2 |
| NOU | Continuous, Ventilator, Home Use | Anesthesiology | 868.5895 | 2 |
| CAW | Generator, Oxygen, Portable | Anesthesiology | 868.5440 | 2 |
| NHJ | Device, Positive Pressure Breathing, Intermittent | Anesthesiology | 868.5905 | 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 | 00850018761451 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K162877 | 000 |