FDA UDI
In Commercial Distribution
🇺🇸 United States
VF1000LED Vein locator
DI: 07898915128789
·
Model: VF1000LEDBX1
·
FABINJECT INDUSTRIA E COMERCIO IMPORTACAO E EXPORTACAO LTDA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VF1000LED Vein locator
- Primary DI
- 07898915128789
- Version / Model
- VF1000LEDBX1
- Company Name
- FABINJECT INDUSTRIA E COMERCIO IMPORTACAO E EXPORTACAO LTDA
- Labeler DUNS
- 902645407
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-07
- Public Version
- 2
- Public Version Date
- 2025-03-03
- Public Version Status
- Update
- Public Device Record Key
- 604f7fc2-ad41-4e02-84ae-ba6f2073933a
Device Description
A device designed to locate veins through cutaneous transillumination.
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
- 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 |
|---|---|---|---|---|
| HJN | Transilluminator, Battery-Powered | Ophthalmic | 886.1945 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36761 | Visible-light skin transilluminator | An electrically-powered device intended to use visible light (e.g., red LED light) to illuminate the skin and subcutaneous soft tissues, rendering them translucent for examination. It is typically used to help locate peripheral veins beneath the skin to assist a healthcare professional during venipuncture or sclerotherapy, or for examining subcutaneous and scrotal tissue/contents for lesions or anatomical abnormalities. It is typically a portable hand-held device which may also be known as a vein finder/viewer, diaphanoscope, phaneroscope, or light scanner. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07898915128789 | GS1 |
Customer Contacts
- Phone
- +551236021415
- [email protected]