FDA UDI
In Commercial Distribution
🇺🇸 United States
Venoscope
DI: B853NT010
·
Model: NT01
·
VENOSCOPE, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Venoscope
- Primary DI
- B853NT010
- Version / Model
- NT01
- Catalog Number
- NT01
- Company Name
- VENOSCOPE, LLC
- Labeler DUNS
- 612726596
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-13
- Public Version
- 1
- Public Version Date
- 2020-03-23
- Public Version Status
- New
- Public Device Record Key
- cd0b5a47-0d90-4737-b943-c1c2df068e4c
Device Description
Handheld battery operated transilluminator used for locating veins for IV therapy and blood draws in small neonate patients.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| HJN | Transilluminator, Battery-Powered | Ophthalmic | 886.1945 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32696 | Skin transilluminator, battery-powered | A hand-held, battery-powered device with a built-in light source, usually together with a lens, intended to be used to illuminate the skin and soft tissues, rendering them translucent for examination. It is typically used to examine subcutaneous and scrotal tissue/contents for lesions, and veins (e.g., on the scalp of an infant) for anatomical abnormalities. This device may also be known as a diaphanoscope, a phaneroscope or a light scanner. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B853NT010 | HIBCC |
Customer Contacts
- Phone
- 800-284-7655
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K941035 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 4.5 | Inch | |
| Width | 2.25 | Inch |