FDA UDI
In Commercial Distribution
🇺🇸 United States
INTERA
DI: 00850014110093
·
Model: IP-37957
·
INTERA ONCOLOGY INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- INTERA
- Primary DI
- 00850014110093
- Version / Model
- IP-37957
- Catalog Number
- IP37957
- Company Name
- INTERA ONCOLOGY INC.
- Labeler DUNS
- 117070072
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-07-13
- Public Version
- 1
- Public Version Date
- 2021-07-21
- Public Version Status
- New
- Public Device Record Key
- a67ad77d-2928-4fff-9f2f-d4696e672903
Device Description
Intera 3000 Hepatic Artery Infusion Pump Tapered Silicone Rubber Catheter (Radiopaque) with Connector. Contents: (1) Catheter: O.D. 2.3mm tapered to O.D. 1.5mm x I.D. 0.6mm x 51.7cm long with (1) Universal Barbed Connector
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
- No
- 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 |
|---|---|---|---|---|
| LKK | Pump, Infusion, Implanted, Programmable | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63949 | Implantable vascular infusion pump catheter | An implantable, flexible tube intended to be connected to an implantable vascular infusion pump in situ and inserted into a blood vessel to deliver pharmaceuticals from the pump to the cardiovascular system. It typically includes connectors and catheter retention components. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850014110093 | GS1 | ||||
| Package | 10850014110090 | GS1 | Box | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- 800-909-4815
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P890055 | 077 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 2.3 | Millimeter | |
| Outer Diameter | 1.5 | Millimeter | |
| Catheter Inner Diameter | 0.6 | Millimeter | |
| Length | 51.7 | Centimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not use if opened or damaged.