FDA UDI
In Commercial Distribution
🇺🇸 United States
Vented Needle
DI: 04022495769893
·
Model: 415072
·
B. BRAUN MEDICAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Basic Information
- Brand Name
- Vented Needle
- Primary DI
- 04022495769893
- Version / Model
- 415072
- Catalog Number
- 415072
- Company Name
- B. BRAUN MEDICAL INC.
- Labeler DUNS
- 002397347
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2019-08-09
- Public Version Status
- Update
- Public Device Record Key
- 7c5421f1-bf2f-4fd1-a597-6fd5019c7313
Device Description
Lateral Flow Vented Needle
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
- Yes
- 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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GAA | NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16628 | Medication transfer needle, vented | A slender, rigid, sharp or blunt tube intended to be attached to a syringe and typically used in the pharmacy to aspirate and transfer fluid medication from a vial/ampule to another container for medication preparation or other purposes. It includes a thin channel cut along its outer surface forming an integral vent that relieves any back pressure in the vial during the transfer of medication [e.g., transfer of drugs from vials to intravenous (IV) bags, filling vials] to help minimize risk of contamination; it does not include a filter. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04022495769893 | GS1 | ||||
| Unit of Use | 04046964189500 | GS1 |
Customer Contacts
- Phone
- +1(800)227-2862
- [email protected]