Adelante® Breezeway® AB1061FT
GUDID 17640142810893
Delivery Sheath, 10F
Oscor Inc.
Vascular guide-catheter, single-use| Primary Device ID | 17640142810893 |
| NIH Device Record Key | 42873839-506e-4683-952f-e3abef73426b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Adelante® Breezeway® |
| Version Model Number | AB1061FT |
| Catalog Number | AB1061FT |
| Company DUNS | 101835833 |
| Company Name | Oscor Inc. |
| 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 | 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 |
Customer Support Contacts
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com | |
| Phone | +1(727)937-2511 |
| sales@oscor.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
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Operating and Storage Conditions
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 17640142810893 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K101497
FDA Product Code
| DYB | INTRODUCER, CATHETER |
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 | 2017-11-19 |
Devices Manufactured by Oscor Inc.
| 00885672012793 - Destino Twist HTS Steerable Guiding Sheath | 2025-10-03 Steerable Guiding Sheath, 12F |
| 00885672012809 - Destino Twist HTS Steerable Guiding Sheath | 2025-10-03 Steerable Guiding Sheath, 12F |
| 00836559001904 - Temporary Myocardial Heartwire | 2025-09-23 Temporary Myocardial Heartwire |
| 00836559001911 - Temporary Myocardial Heartwire | 2025-09-23 Temporary Myocardial Heartwire |
| 00885672012700 - Breezeway II® Plus Delivery Sheath | 2025-06-13 DELIVERY SHEATH PLUS 14F, 79CM |
| 00885672012717 - Breezeway II® Plus Delivery Sheath | 2025-06-13 DELIVERY SHEATH PLUS 14F, 79CM |
| 00885672012694 - SafeSheath® II | 2024-11-05 Hemostatic Tear-away Introducer, 9F |
| 00885672012632 - SafeSheath® II | 2024-07-25 Hemostatic Tear-away Introducer System with Infusion Side Port, 9F, 30 cm |
Trademark Results [Adelante]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ADELANTE 97617073 not registered Live/Pending |
Adelante Shoe Co. 2022-10-03 |
 ADELANTE 88775863 not registered Live/Pending |
Adelante Developtment Center, Inc. 2020-01-28 |
 ADELANTE 88482127 not registered Live/Pending |
Christopher Columbus High School Inc. 2019-06-20 |
 ADELANTE 87787507 5668744 Live/Registered |
Xiamen Visual Beauty Import&Export Co.,Ltd. 2018-02-07 |
 ADELANTE 87787484 not registered Dead/Abandoned |
Xiamen Visual Beauty Import&Export Co.,Ltd. 2018-02-07 |
 ADELANTE 87384051 5373372 Live/Registered |
Jingjie shen 2017-03-24 |
 ADELANTE 87061480 5123634 Live/Registered |
S&R Wines, LLC 2016-06-06 |
 ADELANTE 79009793 3335333 Dead/Cancelled |
NXP B.V. 2004-12-03 |
 ADELANTE 78891040 3500234 Dead/Cancelled |
ADELANTE EDUCATIONAL SERVICES LLC 2006-05-24 |
 ADELANTE 78718857 3246332 Dead/Cancelled |
AT&T INTELLECTUAL PROPERTY II, L.P. 2005-09-22 |
 ADELANTE 78419654 3110207 Live/Registered |
Oscor Inc. 2004-05-17 |
 ADELANTE 78373666 3125647 Live/Registered |
Banco Bilbao Vizcaya Argentaria, S.A. 2004-02-25 |
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