FDA UDI
Not in Commercial Distribution
🇺🇸 United States
XO Cross 14
DI: B090C141350
·
Model: C14-135
·
ZIEN MEDICAL TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- XO Cross 14
- Primary DI
- B090C141350
- Version / Model
- C14-135
- Catalog Number
- C14-135
- Company Name
- ZIEN MEDICAL TECHNOLOGIES, INC.
- Labeler DUNS
- 017535668
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-20
- Public Version
- 2
- Public Version Date
- 2024-06-20
- Public Version Status
- Update
- Public Device Record Key
- 28a0ddc6-4291-4b2b-91b7-7b7ffebbe7da
- Distribution End Date
- 2022-06-20
Device Description
The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
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 |
|---|---|---|---|---|
| DQY | Catheter, Percutaneous | Cardiovascular | 870.1250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17846 | Vascular guide-catheter, single-use | A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | B090C141351 | HIBCC | Shelf Carton | 1 | Not in Commercial Distribution | 2022-06-20 |
| Primary | B090C141350 | HIBCC | ||||
| Package | B090C141352 | HIBCC | Shipper | 10 | Not in Commercial Distribution | 2022-06-20 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 2 | French | |
| Catheter Working Length | 135 | Centimeter | |
| Crossing Profile | 1.6 | French | |
| Introducer Sheath Compatibility | 2.9 | French |