FDA UDI
In Commercial Distribution
🇺🇸 United States
INTROCAN SAFETY®
DI: 04046964478635
·
Model: 4252551-020
·
B. BRAUN MEDICAL INC.
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
Basic Information
- Brand Name
- INTROCAN SAFETY®
- Primary DI
- 04046964478635
- Version / Model
- 4252551-020
- Catalog Number
- 4252551-020
- Company Name
- B. BRAUN MEDICAL INC.
- Labeler DUNS
- 002397347
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 13
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- 8c735e78-ce57-41c3-a587-b0096d44a986
Device Description
INTROCAN SAFETY FEP 18G, 1.3X45MM-US
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
- 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 |
|---|---|---|---|---|
| DYB | INTRODUCER, CATHETER | Cardiovascular | 870.1340 | 2 |
| FOZ | Catheter,intravascular,therapeutic,short-term less than 30 days | General Hospital | 880.5200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32151 | Peripheral vascular intervention infusion catheter | A flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature during a cardiovascular procedure (e.g., delivery of an antithrombotic agent); some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced and may include features such as side holes for infusion across a specific region, an expanding frame to disrupt clotted blood to improve diffusion, or a balloon to support infusion at a specific region. It is neither a peripherally-inserted central venous catheter, dedicated occluding catheter, nor superselective small vessel microcatheter. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04046964478642 | GS1 | Carton | 4 | In Commercial Distribution | |
| Primary | 04046964478635 | GS1 | ||||
| Unit of Use | 04046964477546 | GS1 |
Customer Contacts
- Phone
- +1(800)227-2862
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Catheter-Gauge : 18 |