Enteer ENB-375-20-135
GUDID 00821684052747
Re-entry Catheter
Covidien LP
Vascular guide-catheter, single-use| Primary Device ID | 00821684052747 |
| NIH Device Record Key | e287687f-1e18-4806-9a63-4eaa1090e987 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Enteer |
| Version Model Number | ENB-375-20-135 |
| Catalog Number | ENB-375-20-135 |
| Company DUNS | 968903703 |
| 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 | false |
| 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 | |
| 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 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.75 Millimeter |
| Length | 20 Millimeter |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.75 Millimeter |
| Length | 20 Millimeter |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.75 Millimeter |
| Length | 20 Millimeter |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.75 Millimeter |
| Length | 20 Millimeter |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.75 Millimeter |
| Length | 20 Millimeter |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.75 Millimeter |
| Length | 20 Millimeter |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.75 Millimeter |
| Length | 20 Millimeter |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.75 Millimeter |
| Length | 20 Millimeter |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.75 Millimeter |
| Length | 20 Millimeter |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.75 Millimeter |
| Length | 20 Millimeter |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.75 Millimeter |
| Length | 20 Millimeter |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.75 Millimeter |
| Length | 20 Millimeter |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.75 Millimeter |
| Length | 20 Millimeter |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.75 Millimeter |
| Length | 20 Millimeter |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.75 Millimeter |
| Length | 20 Millimeter |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.75 Millimeter |
| Length | 20 Millimeter |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.75 Millimeter |
| Length | 20 Millimeter |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.75 Millimeter |
| Length | 20 Millimeter |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.75 Millimeter |
| Length | 20 Millimeter |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.75 Millimeter |
| Length | 20 Millimeter |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.75 Millimeter |
| Length | 20 Millimeter |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.75 Millimeter |
| Length | 20 Millimeter |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.75 Millimeter |
| Length | 20 Millimeter |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.75 Millimeter |
| Length | 20 Millimeter |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.75 Millimeter |
| Length | 20 Millimeter |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.75 Millimeter |
| Length | 20 Millimeter |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.75 Millimeter |
| Length | 20 Millimeter |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.75 Millimeter |
| Length | 20 Millimeter |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.75 Millimeter |
| Length | 20 Millimeter |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.75 Millimeter |
| Length | 20 Millimeter |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.75 Millimeter |
| Length | 20 Millimeter |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.75 Millimeter |
| Length | 20 Millimeter |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.75 Millimeter |
| Length | 20 Millimeter |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.75 Millimeter |
| Length | 20 Millimeter |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.75 Millimeter |
| Length | 20 Millimeter |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.75 Millimeter |
| Length | 20 Millimeter |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.75 Millimeter |
| Length | 20 Millimeter |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.75 Millimeter |
| Length | 20 Millimeter |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Outer Diameter | 3.75 Millimeter |
| Length | 20 Millimeter |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00821684052747 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K120533
FDA Product Code
| DQY | CATHETER, PERCUTANEOUS |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-01-23 |
| Device Publish Date | 2015-10-09 |
On-Brand Devices [Enteer]
| 00821684052778 | Guidewire;Stiff |
| 00821684052761 | Guidewire;Standard |
| 00821684052754 | Guidewire;Flexible |
| 00821684052747 | Re-entry Catheter |
| 00821684052730 | Re-entry Catheter |
Trademark Results [Enteer]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENTEER 87344866 5397871 Live/Registered |
Lin BaoLiu 2017-02-22 |
 ENTEER 85631486 4485816 Live/Registered |
COVIDIEN LP 2012-05-22 |
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