FDA UDI
Not in Commercial Distribution
🇺🇸 United States
B.BRAUN
DI: 04046964310621
·
Model: 613402
·
B BRAUN INTERVENTIONAL SYSTEMS, INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- B.BRAUN
- Primary DI
- 04046964310621
- Version / Model
- 613402
- Catalog Number
- 613402
- Company Name
- B BRAUN INTERVENTIONAL SYSTEMS, INC
- Labeler DUNS
- 784259751
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2015-07-22
- Public Version
- 7
- Public Version Date
- 2022-11-02
- Public Version Status
- Update
- Public Device Record Key
- 62b29c6d-2950-45b8-9d6d-19e8e69e28d7
- Distribution End Date
- 2016-07-11
Device Description
4F PICC SINGLE 50 NITGLD130 CTS450-NG130
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- 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 |
|---|---|---|---|---|
| LJS | Catheter,intravascular,therapeutic,long-term greater than 30 days | General Hospital | 880.5970 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36257 | Peripherally-inserted central venous catheter | A thin, flexible tube intended to be introduced into a peripheral vein and advanced to a central vein for short- to long-term intravascular access to administer medications (antibiotics), chemotherapeutic agents, nutrients, parenteral solutions, pain management fluids, and sometimes for blood sampling, monitoring of blood pressure and temperature, and for power injection of contrast media; it is not primarily intended for extracorporeal blood therapies such as haemodialysis. Also known as a peripherally inserted central catheter (PICC), it typically includes dedicated accessories to facilitate catheter introduction/function (e.g., Luer hubs, stylet). This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04046964310621 | GS1 | ||||
| Unit of Use | 04046964310607 | GS1 |
Customer Contacts
- Phone
- +1(877)836-2228
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K083873 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Length of guidewire : 130.000 CM | ||
| Catheter Gauge | 4.00 | French | |
| Device Size Text, specify | Length of catheter : 50.000 CM |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- ROOM TEMP
- Type
- Special Storage Condition, Specify
- Special Conditions
- KEEP DRY
- Type
- Special Storage Condition, Specify
- Special Conditions
- KEEP AWAY FROM SUNLIGHT.