FDA UDI
In Commercial Distribution
🇺🇸 United States
BIO-PRF
DI: 00841336112124
·
Model: BIO-PRF-IV-Connect
·
SALVIN DENTAL SPECIALTIES, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- BIO-PRF
- Primary DI
- 00841336112124
- Version / Model
- BIO-PRF-IV-Connect
- Company Name
- SALVIN DENTAL SPECIALTIES, LLC
- Labeler DUNS
- 113344790
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-26
- Public Version
- 1
- Public Version Date
- 2025-03-06
- Public Version Status
- New
- Public Device Record Key
- c96832b8-4740-40cb-8481-f6f90f4db8e5
Device Description
BIO-PRF IV Connectors - Large IV Tube Holders
Device Characteristics
- Single Use
- Yes
- 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
- 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 |
|---|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | 880.5570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65416 | Basic intravenous administration set, invasive | A collection of devices which includes a hypodermic needle (e.g., venous butterfly/scalp vein needle) intended to conduct fluids from an intravenous (IV) fluid container to a patient's venous system during administration; it may also be used for blood collection. In addition to the needle, the set may include tubing, connectors, chambers, clamps, gauze pads, alcohol pads and dressings; a bag/bottle may also be included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10841336112121 | GS1 | Inner | 100 | In Commercial Distribution | |
| Primary | 00841336112124 | GS1 |
Customer Contacts
- Phone
- 800-535-6566
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K011786 | 000 |