Primary Device ID | B090E20130S1 |
NIH Device Record Key | 51e709ac-971a-485a-b5c1-436290881f74 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | XO Cath |
Version Model Number | E20-130-S |
Catalog Number | E20-130-S |
Company DUNS | 017535668 |
Company Name | ZIEN MEDICAL TECHNOLOGIES, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Unsafe |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Catheter Length | 130 Centimeter |
Catheter Gauge | 2 French |
Catheter Length | 130 Centimeter |
Catheter Gauge | 2 French |
Catheter Length | 130 Centimeter |
Catheter Gauge | 2 French |
Catheter Length | 130 Centimeter |
Catheter Gauge | 2 French |
Catheter Length | 130 Centimeter |
Catheter Gauge | 2 French |
Catheter Length | 130 Centimeter |
Catheter Gauge | 2 French |
Catheter Length | 130 Centimeter |
Catheter Gauge | 2 French |
Catheter Length | 130 Centimeter |
Catheter Gauge | 2 French |
Catheter Length | 130 Centimeter |
Catheter Gauge | 2 French |
Catheter Length | 130 Centimeter |
Catheter Gauge | 2 French |
Catheter Length | 130 Centimeter |
Catheter Gauge | 2 French |
Catheter Length | 130 Centimeter |
Catheter Gauge | 2 French |
Catheter Length | 130 Centimeter |
Catheter Gauge | 2 French |
Catheter Length | 130 Centimeter |
Catheter Gauge | 2 French |
Catheter Length | 130 Centimeter |
Catheter Gauge | 2 French |
Catheter Length | 130 Centimeter |
Catheter Gauge | 2 French |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B090E20130S0 [Primary] |
HIBCC | B090E20130S1 [Package] Contains: B090E20130S0 Package: Shelf Carton [1 Units] In Commercial Distribution |
HIBCC | B090E20130S2 [Package] Package: Shipper [10 Units] In Commercial Distribution |
KRA | Catheter, Continuous Flush |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-05-08 |
Device Publish Date | 2024-04-30 |
B090E20130S1 | The XO Cath microcatheter is intended for peripheral vascular use. The microcatheter can be used |
B090E20130B1 | The XO Cath microcatheter is intended for peripheral vascular use. The microcatheter can be used |