FDA UDI
In Commercial Distribution
🇺🇸 United States
ARROW
DI: 10801902001198
·
Model: IPN030849
·
TELEFLEX INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- ARROW
- Primary DI
- 10801902001198
- Version / Model
- IPN030849
- Catalog Number
- CV-12122-UF
- Company Name
- TELEFLEX INCORPORATED
- Labeler DUNS
- 002348191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-13
- Public Version
- 5
- Public Version Date
- 2021-12-22
- Public Version Status
- Update
- Public Device Record Key
- bd9a4ddd-be61-4b9c-8dfc-e28e6793739f
Device Description
You-Bend(TM) Two-Lumen Hemodialysis Catheterization Set with Blue FlexTip® Catheter for High Volume Infusions
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
- MR Conditional
- Direct Marking Exempt
- Yes
- 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 |
|---|---|---|---|---|
| MPB | Catheter, hemodialysis, non-implanted | Gastroenterology, Urology | 876.5540 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46979 | Double-lumen haemodialysis catheter, nonimplantable | A flexible, double-lumen tube intended to be used for short-term (< 30 days) central venous (jugular, subclavian vein) and/or femoral vein access, primarily during haemodialysis, to conduct blood from a patient and returning it after extracorporeal circulation; it may also be used during haemoperfusion and/or apheresis. It is intended for coaxial flow of blood and may be radiopaque; devices dedicated to catheter introduction/function (e.g., introducer needle) may be included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20801902001195 | GS1 | Case | 5 | In Commercial Distribution | |
| Primary | 10801902001198 | GS1 |
Customer Contacts
- Phone
- +1(919)544-8000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K991431 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 16 | Centimeter | |
| Catheter Gauge | 12 | French |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 25 Degrees Celsius