Tandem-Cath 8888223266
GUDID 10884521009967
Chronic Dual Catheter System,23 cm Arterial Cuff / 26 cm Venous Cuff, Sideholes,10 Fr/Ch (3.3 mm)
Covidien LP
Double-lumen haemodialysis catheter, implantable| Primary Device ID | 10884521009967 |
| NIH Device Record Key | ec16e233-e64d-49a6-bb07-7a2eaf7b081d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tandem-Cath |
| Version Model Number | 8888223266 |
| Catalog Number | 8888223266 |
| Company DUNS | 058614483 |
| Company Name | Covidien LP |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
Customer Support Contacts
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Catheter Gauge | 10 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 10 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 10 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 10 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 10 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 10 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 10 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 10 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 10 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 10 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 10 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 10 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 10 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 10 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 10 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 10 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 10 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 10 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 10 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 10 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 10 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 10 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 10 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 10 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 10 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 10 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 10 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 10 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 10 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 10 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 10 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 10 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 10 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 10 French |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *;AVOID DIRECT SUNLIGHT |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10884521009967 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K041006
FDA Product Code
| MSD | Catheter, hemodialysis, implanted |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-02-05 |
| Device Publish Date | 2014-09-22 |
On-Brand Devices [Tandem-Cath]
| 20884521009971 | Chronic Dual Catheter System,28 cm Arterial Cuff / 31 cm Venous Cuff, Sideholes,10 Fr/Ch (3.3 mm |
| 20884521009957 | Chronic Dual Catheter System,19 cm Arterial Cuff / 22 cm Venous Cuff, Sideholes,10 Fr/Ch (3.3 mm |
| 20884521009940 | Chronic Dual Catheter System Repair Kit,Back-End,10 Fr/Ch (3.3 mm) |
| 10884521009967 | Chronic Dual Catheter System,23 cm Arterial Cuff / 26 cm Venous Cuff, Sideholes,10 Fr/Ch (3.3 mm |
Trademark Results [Tandem-Cath]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TANDEM-CATH 78035291 2799065 Live/Registered |
COVIDIEN AG 2000-11-14 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.