FDA UDI
In Commercial Distribution
🇺🇸 United States
SURECAN SAFETY II
DI: 04046955156399
·
Model: 4447051-02
·
B. BRAUN MEDICAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
20
Basic Information
- Brand Name
- SURECAN SAFETY II
- Primary DI
- 04046955156399
- Version / Model
- 4447051-02
- Catalog Number
- 4447051-02
- Company Name
- B. BRAUN MEDICAL INC.
- Labeler DUNS
- 002397347
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2017-12-22
- Public Version
- 7
- Public Version Date
- 2020-03-03
- Public Version Status
- Update
- Public Device Record Key
- 10220021-240f-42d5-bdb2-0b2495830b6f
Device Description
Surecan™ Safety II Port Access Needle Set with Caresite® Y Injection Site 20G x 0.8 in. (20mm)
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
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| PTI | Non-Coring (Huber) Needle | General Hospital | 880.5570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17701 | Vascular port administration set | A collection of devices designed to conduct fluids from an intravenous (IV) fluid container to a patient's venous system via a previously implanted injection/infusion port. It typically includes a noncoring needle designed with a lateral hole (side-hole), tubing, connectors, chambers, clamps and may include an injection placement aid. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04046964999956 | GS1 | Carton | 5 | In Commercial Distribution | |
| Primary | 04046955156399 | GS1 | ||||
| Unit of Use | 04046964858581 | GS1 |
Customer Contacts
- Phone
- +1(800)227-2862
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Length of cannula (metric) : 20.000 MM | ||
| Device Size Text, specify | Gauge (cannula) : 20 |