FDA UDI
In Commercial Distribution
🇺🇸 United States
Xcela
DI: H965451120
·
Model: H965451120
·
NAVILYST MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Xcela
- Primary DI
- H965451120
- Version / Model
- H965451120
- Company Name
- NAVILYST MEDICAL, INC.
- Labeler DUNS
- 809699023
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-17
- Public Version
- 4
- Public Version Date
- 2022-02-11
- Public Version Status
- Update
- Public Device Record Key
- b3213d14-1954-4737-ada3-865dd1ab5b62
Device Description
8F x 750mm Xcela Low Profile Titanium Power Injectable Port
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 |
|---|---|---|---|---|
| LJT | PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR | General Hospital | 880.5965 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61494 | Vascular port/catheter | A fully-implantable device assembly intended to provide access to arteries/veins (excludes coronary and intracerebral circulation) for infusion (e.g., chemotherapeutic agents, blood transfusions) and/or drainage (e.g., blood). It consists of: 1) a subcutaneous chamber, with a self-sealing puncturable septum for percutaneous insertion of a hypodermic needle; and 2) an attached catheter which passes into the arteries/veins. It may consist of two chambers attached to a dual-lumen catheter for simultaneous infusion. It is made of metal [e.g., titanium (Ti)] and/or synthetic polymers (e.g., silicone); disposable devices associated with implantation may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | H965451120 | HIBCC | ||||
| Secondary | 07640110982242 | GS1 |
Customer Contacts
- Phone
- +1(518)795-1676
- [email protected]
Premarket Submissions
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Lumen/Inner Diameter | 1.6 | Millimeter | |
| Outer Diameter | 2.6 | Millimeter | |
| Needle Gauge | 17 | Gauge | |
| Catheter Gauge | 8 | French | |
| Length | 750 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 30 Degrees Celsius