FDA UDI
In Commercial Distribution
🇺🇸 United States
ARROW
DI: 00801902096005
·
Model: IPN032578
·
TELEFLEX INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- ARROW
- Primary DI
- 00801902096005
- Version / Model
- IPN032578
- Catalog Number
- AC-15312-XCO
- Company Name
- TELEFLEX INCORPORATED
- Labeler DUNS
- 002348191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-16
- Public Version
- 5
- Public Version Date
- 2021-02-05
- Public Version Status
- Update
- Public Device Record Key
- 060605cd-0773-4061-a4f7-6820c98b2d92
Device Description
15 Fr. x 31 cm NextStep(R) Antegrade Hemodialysis Catheter. Long-Term Access. Catheter Length, Tip to Cuff: 31 cm
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
- 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 |
|---|---|---|---|---|
| MSD | Catheter, hemodialysis, implanted | Gastroenterology, Urology | 876.5540 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37278 | Double-lumen haemodialysis catheter, implantable | An implantable, flexible, double-lumen tube intended to be used for chronic or long-term (> 30 days) vascular 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, may be radiopaque, coated with heparin to prevent thrombus formation, and/or include a silver-coated sleeve to retard bacterial growth; devices dedicated to catheter introduction/function (e.g., introducer needle) may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10801902096002 | GS1 | Box | 1 | Not in Commercial Distribution | 2019-01-10 |
| Primary | 00801902096005 | GS1 | ||||
| Package | 30801902096006 | GS1 | Case | 1 | Not in Commercial Distribution | 2019-01-10 |
Customer Contacts
- Phone
- +1(919)544-8000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K111900 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 31 | Centimeter | |
| Catheter Gauge | 15 | French |