PECO
GUDID 10817668010565
Box PECO™ 10" Pediatric, 14 Fr. Straight Intermittent Catheter
PECO MEDICAL INC.
Single-administration urethral drainage catheter| Primary Device ID | 10817668010565 |
| NIH Device Record Key | 687dd2b6-4509-4d85-8220-31336bfff143 |
| Commercial Distribution Discontinuation | 2020-01-10 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | PECO |
| Version Model Number | PU014P |
| Company DUNS | 080120792 |
| Company Name | PECO MEDICAL INC. |
| Device Count | 30 |
| 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Device Dimensions
| Length | 10 Inch |
| Catheter Gauge | 14 French |
| Length | 10 Inch |
| Catheter Gauge | 14 French |
| Length | 10 Inch |
| Catheter Gauge | 14 French |
| Length | 10 Inch |
| Catheter Gauge | 14 French |
| Length | 10 Inch |
| Catheter Gauge | 14 French |
| Length | 10 Inch |
| Catheter Gauge | 14 French |
| Length | 10 Inch |
| Catheter Gauge | 14 French |
| Length | 10 Inch |
| Catheter Gauge | 14 French |
| Length | 10 Inch |
| Catheter Gauge | 14 French |
Operating and Storage Conditions
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817668010568 [Unit of Use] |
| GS1 | 10817668010565 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K111405
FDA Product Code
| GBM | CATHETER, URETHRAL |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10817668010565]
Ethylene Oxide
[10817668010565]
Ethylene Oxide
[10817668010565]
Ethylene Oxide
[10817668010565]
Ethylene Oxide
[10817668010565]
Ethylene Oxide
[10817668010565]
Ethylene Oxide
[10817668010565]
Ethylene Oxide
[10817668010565]
Ethylene Oxide
[10817668010565]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-08-17 |
| Device Publish Date | 2017-09-08 |
On-Brand Devices [PECO]
| 10817668010572 | Box PECO™ 7.5" Female, 14 Fr. Straight Intermittent Catheter |
| 10817668010565 | Box PECO™ 10" Pediatric, 14 Fr. Straight Intermittent Catheter |
| 10817668010558 | Box PECO™ 10" Pediatric, 12 Fr. Straight Intermittent Catheter |
| 10817668010534 | Box PECO™ 16" Male, 10 Fr. Straight Intermittent Catheter |
| 10817668010527 | Box PECO™ 16" Male, 8 Fr. Straight Intermittent Catheter |
| 10817668010510 | Box PECO™ 16" Male, 6 Fr. Straight Intermittent Catheter |
| 10817668010503 | Box PECO™ 10" Pediatric, 6 Fr. Straight Intermittent Catheter |
| 10817668010121 | Box PECO™ 7.5" Female, 8 Fr. Straight Intermittent Catheter |
| 10817668010114 | Box PECO™ 7.5" Female, 18 Fr. Straight Intermittent Catheter |
| 10817668010107 | Box PECO™ 7.5" Female, 16 Fr. Straight Intermittent Catheter |
| 10817668010091 | Box PECO™ 7.5" Female, 14 Fr. Straight Intermittent Catheter |
| 10817668010084 | Box PECO™ 7.5" Female, 12 Fr. Straight Intermittent Catheter |
| 10817668010077 | Box PECO™ 7.5" Female, 10 Fr. Straight Intermittent Catheter |
| 10817668010060 | Box PECO™ 16" Male, 18 Fr. Straight Intermittent Catheter |
| 10817668010053 | Box PECO™ 16" Male, 16 Fr. Straight Intermittent Catheter |
| 10817668010046 | Box PECO™ 16" Male, 14 Fr. Straight Intermittent Catheter |
| 10817668010039 | Box PECO™ 16" Male, 12 Fr. Straight Intermittent Catheter |
| 10817668010022 | Box PECO™ 10" Pediatric, 10 Fr. Straight Intermittent Catheter |
| 10817668010015 | Box PECO™ 10" Pediatric, 8 Fr. Straight Intermittent Catheter |
Trademark Results [PECO]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PECO 97795554 not registered Live/Pending |
Peco US LLC 2023-02-15 |
 PECO 97609431 not registered Live/Pending |
PECOTEK CO. LTD. 2022-09-27 |
 PECO 90410767 not registered Live/Pending |
Requisite Solutions Inc. 2020-12-24 |
 PECO 90380462 not registered Live/Pending |
Molekule, Inc. 2020-12-14 |
 PECO 88174025 not registered Live/Pending |
Molekule, Inc. 2018-10-30 |
 PECO 87326442 5280574 Live/Registered |
PECO MEDICAL, INC. 2017-02-07 |
 PECO 87276704 not registered Dead/Abandoned |
PRITCHARD PATENT PRODUCT CO. LIMITED 2016-12-21 |
 PECO 86452082 4937684 Live/Registered |
PECOTEK CO. LTD. 2014-11-12 |
PECO 86452082 4937684 Live/Registered |
LEE, Hyang Ee 2014-11-12 |
 PECO 78665433 3109254 Live/Registered |
Peco Foods, Inc. 2005-07-07 |
 PECO 78329474 2997053 Live/Registered |
Peco Corporation 2003-11-18 |
 PECO 77003360 not registered Dead/Abandoned |
PECO FASTENERS, INC. 2006-09-20 |
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