Enteer™
GUDID 00821684073797
CATH ENB-375-20-135 CTO RE-ENTRY V03
Covidien LP
Vascular guide-catheter, single-use| Primary Device ID | 00821684073797 |
| NIH Device Record Key | d7aeb0b6-4426-4a5d-93f0-d6891e26a495 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Enteer™ |
| Version Model 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 | false |
| 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
Device Dimensions
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Catheter Gauge | 5 French |
| Length | 135 Centimeter |
| Catheter Gauge | 5 French |
| Length | 135 Centimeter |
| Catheter Gauge | 5 French |
| Length | 135 Centimeter |
| Catheter Gauge | 5 French |
| Length | 135 Centimeter |
| Catheter Gauge | 5 French |
| Length | 135 Centimeter |
| Catheter Gauge | 5 French |
| Length | 135 Centimeter |
| Catheter Gauge | 5 French |
| Length | 135 Centimeter |
| Catheter Gauge | 5 French |
| Length | 135 Centimeter |
| Catheter Gauge | 5 French |
| Length | 135 Centimeter |
| Catheter Gauge | 5 French |
| Length | 135 Centimeter |
| Catheter Gauge | 5 French |
| Length | 135 Centimeter |
| Catheter Gauge | 5 French |
| Length | 135 Centimeter |
| Catheter Gauge | 5 French |
| Length | 135 Centimeter |
| Catheter Gauge | 5 French |
| Length | 135 Centimeter |
| Catheter Gauge | 5 French |
| Length | 135 Centimeter |
| Catheter Gauge | 5 French |
| Length | 135 Centimeter |
| Catheter Gauge | 5 French |
| Length | 135 Centimeter |
| Catheter Gauge | 5 French |
| Length | 135 Centimeter |
| Catheter Gauge | 5 French |
| Length | 135 Centimeter |
| Catheter Gauge | 5 French |
| Length | 135 Centimeter |
| Catheter Gauge | 5 French |
| Length | 135 Centimeter |
| Catheter Gauge | 5 French |
| Length | 135 Centimeter |
| Catheter Gauge | 5 French |
| Length | 135 Centimeter |
| Catheter Gauge | 5 French |
| Length | 135 Centimeter |
| Catheter Gauge | 5 French |
| Length | 135 Centimeter |
| Catheter Gauge | 5 French |
| Length | 135 Centimeter |
| Catheter Gauge | 5 French |
| Length | 135 Centimeter |
| Catheter Gauge | 5 French |
| Length | 135 Centimeter |
| Catheter Gauge | 5 French |
| Length | 135 Centimeter |
| Catheter Gauge | 5 French |
| Length | 135 Centimeter |
| Catheter Gauge | 5 French |
| Length | 135 Centimeter |
| Catheter Gauge | 5 French |
| Length | 135 Centimeter |
| Catheter Gauge | 5 French |
| Length | 135 Centimeter |
| Catheter Gauge | 5 French |
| Length | 135 Centimeter |
| Catheter Gauge | 5 French |
| Length | 135 Centimeter |
| Catheter Gauge | 5 French |
| Length | 135 Centimeter |
| Catheter Gauge | 5 French |
| Length | 135 Centimeter |
| Catheter Gauge | 5 French |
| Length | 135 Centimeter |
| Catheter Gauge | 5 French |
| Length | 135 Centimeter |
| Catheter Gauge | 5 French |
| Length | 135 Centimeter |
| Catheter Gauge | 5 French |
| Length | 135 Centimeter |
| Catheter Gauge | 5 French |
| Length | 135 Centimeter |
| Catheter Gauge | 5 French |
| Length | 135 Centimeter |
| Catheter Gauge | 5 French |
| Length | 135 Centimeter |
| Catheter Gauge | 5 French |
| Length | 135 Centimeter |
Operating and Storage Conditions
| 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 away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00821684073797 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
FDA Product Code
| PDU | Catheter for crossing total occlusions |
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 | 2016-09-18 |
On-Brand Devices [Enteer™]
| 00821684073841 | GW ENW-SF-014-300 CTO RE-ENTRY V03 |
| 00821684073834 | GW ENW-SD-014-300 CTO RE-ENTRY V03 |
| 00821684073827 | GW ENW-FX-014-300 CTO RE-ENTRY V03 |
| 00821684073797 | CATH ENB-375-20-135 CTO RE-ENTRY V03 |
| 00821684073780 | CATH ENB-275-20-150 CTO RE-ENTRY V03 |
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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