FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 04046964347481
·
Model: 7L3052
·
B. BRAUN MEDICAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
500
Basic Information
- Brand Name
- NA
- Primary DI
- 04046964347481
- Version / Model
- 7L3052
- Catalog Number
- 7L3052
- Company Name
- B. BRAUN MEDICAL INC.
- Labeler DUNS
- 002397347
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 500
- Record Status
- Published
- Publish Date
- 2016-08-18
- Public Version
- 4
- Public Version Date
- 2021-05-28
- Public Version Status
- Update
- Public Device Record Key
- 0b0945e0-d4be-4a73-b17a-24d0477d2afb
Device Description
SIGMA-TAU 19 G HIGH FLOW FILTER NDL
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 |
|---|---|---|---|---|
| 16266 | Medication transfer needle, filtering | 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 an integral filter (e.g., a microporous stainless steel filter) intended to retain micro-particles from the drug as it flows through the needle to reduce the risk of particle contamination of the patient medication; it does not include a back-pressure venting feature. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04046964347481 | GS1 | ||||
| Unit of Use | 04046964347467 | GS1 |
Customer Contacts
- Phone
- +1(888)822-7286
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Length of cannula (inch) : 1 1/8" | ||
| Device Size Text, specify | Length of cannula (metric) : 3.000 CM | ||
| Device Size Text, specify | Gauge (cannula) : 19 |