Flexon
GUDID 20884521103747
Multifilament Temporary Cardiac Pacing Lead
Covidien LP
Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead Transthoracic pacing lead| Primary Device ID | 20884521103747 |
| NIH Device Record Key | 0c5a8f5b-37fd-446a-bf4f-e4dfe6887bb4 |
| Commercial Distribution Discontinuation | 2021-07-09 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Flexon |
| Version Model Number | 88862591-43 |
| 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 | 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
| 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 | |
| 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
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
| Length | 24 Inch |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10884521103740 [Primary] |
| GS1 | 20884521103747 [Package] Contains: 10884521103740 Package: CASE [12 Units] Discontinued: 2021-07-09 Not in Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K955722
FDA Product Code
| LDF | ELECTRODE, PACEMAKER, TEMPORARY |
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 | 2021-07-13 |
| Device Publish Date | 2015-08-31 |
On-Brand Devices [Flexon]
| 20884521103747 | Multifilament Temporary Cardiac Pacing Lead |
| 20884521757575 | Multifilament Temporary Cardiac Pacing Lead |
| 20884521757568 | Multifilament Temporary Cardiac Pacing Lead |
| 20884521757551 | Multifilament Temporary Cardiac Pacing Lead |
| 20884521757544 | Multifilament Temporary Cardiac Pacing Lead |
| 20884521103808 | Multifilament Temporary Cardiac Pacing Lead |
| 20884521103792 | Multifilament Temporary Cardiac Pacing Lead |
| 20884521103785 | Multifilament Temporary Cardiac Pacing Lead |
| 20884521103778 | Multifilament Temporary Cardiac Pacing Lead |
| 20884521103761 | Multifilament Temporary Cardiac Pacing Lead |
| 20884521103754 | Multifilament Temporary Cardiac Pacing Lead |
| 20884521103730 | Multifilament Temporary Cardiac Pacing Lead |
| 20884521103716 | Multifilament Temporary Cardiac Pacing Lead |
Trademark Results [Flexon]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FLEXON 97622891 not registered Live/Pending |
Hickory Brands, Inc. 2022-10-07 |
 FLEXON 88720976 not registered Live/Pending |
Flexon Clothing LLC 2019-12-10 |
 FLEXON 88624735 not registered Live/Pending |
U.S. WIRE & CABLE CORPORATION 2019-09-20 |
 FLEXON 88624698 not registered Live/Pending |
U.S. WIRE & CABLE CORPORATION 2019-09-20 |
 FLEXON 88084454 not registered Dead/Abandoned |
Babichenko, Pavel 2018-08-20 |
 FLEXON 87939249 not registered Live/Pending |
Flexon Industries Corporation 2018-05-29 |
 FLEXON 87730233 5645120 Live/Registered |
COFLEX, S.A. de C.V. 2017-12-21 |
 FLEXON 87659811 5559453 Live/Registered |
Exxon Mobil Corporation 2017-10-25 |
 FLEXON 87405680 not registered Live/Pending |
Wilbur-Ellis Company LLC 2017-04-10 |
 FLEXON 86105433 not registered Dead/Abandoned |
Wilbur-Ellis Company 2013-10-30 |
 FLEXON 85034028 not registered Dead/Abandoned |
Wilbur-Ellis Company 2010-05-10 |
 FLEXON 79068337 3892605 Live/Registered |
Joh. Winklhofer Beteiligungs; GmbH & Co. KG 2008-12-15 |
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