Igloo® Wound Irrigation OTC 601
GUDID 20859911004027
Wound Irrigation
Bionix, LLC
Wound shield| Primary Device ID | 20859911004027 |
| NIH Device Record Key | ffa3a353-08fd-4474-9fb6-7bc03365a0da |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Igloo® Wound Irrigation OTC |
| Version Model Number | 601 |
| Catalog Number | 601 |
| Company DUNS | 117844489 |
| Company Name | Bionix, LLC |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00859911004023 [Primary] |
| GS1 | 20859911004027 [Package] Contains: 00859911004023 Package: [12 Units] In Commercial Distribution |
FDA Product Code
| KYZ | SYRINGE, IRRIGATING (NON DENTAL) |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[20859911004027]
Radiation Sterilization
[20859911004027]
Radiation Sterilization
[20859911004027]
Radiation Sterilization
[20859911004027]
Radiation Sterilization
[20859911004027]
Radiation Sterilization
[20859911004027]
Radiation Sterilization
[20859911004027]
Radiation Sterilization
[20859911004027]
Radiation Sterilization
[20859911004027]
Radiation Sterilization
[20859911004027]
Radiation Sterilization
[20859911004027]
Radiation Sterilization
[20859911004027]
Radiation Sterilization
[20859911004027]
Radiation Sterilization
[20859911004027]
Radiation Sterilization
[20859911004027]
Radiation Sterilization
[20859911004027]
Radiation Sterilization
[20859911004027]
Radiation Sterilization
[20859911004027]
Radiation Sterilization
[20859911004027]
Radiation Sterilization
[20859911004027]
Radiation Sterilization
[20859911004027]
Radiation Sterilization
[20859911004027]
Radiation Sterilization
[20859911004027]
Radiation Sterilization
[20859911004027]
Radiation Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-07-22 |
| Device Publish Date | 2022-07-14 |
Devices Manufactured by Bionix, LLC
| 00714646000606 - Igloo Wound Irrigator | 2024-10-03 Wound Irrigation - Sample |
| 10714646000665 - ShotBlocker® | 2024-09-26 5 ct ShotBlocker |
| 10714646000849 - ShotBlocker® | 2024-09-26 ShotBlocker® 2000 ct. Retail |
| 20714646000860 - SafeStraw™ 2 Pack | 2024-09-26 SafeStraw™ 2 Pack |
| 10714646000993 - Opti-Tatt™ Dots | 2024-09-26 Opti-Tatt, Dot, Sheet of 24 |
| 10714646001006 - Opti-Tatt™ Crosshairs | 2024-09-26 Opti-Tatt, Crosshair, Sheet of 24 |
| 10714646001013 - Opti-Tatt™ Field Borders | 2024-09-26 Opti-Tatt, Field Border, Sheet of 24 |
| 10714646001020 - Sample: Opti-Tatt Dots | 2024-09-26 Sample: Opti-Tatt, Dot, Sheet of 3 |
Trademark Results [Igloo]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IGLOO 98440130 not registered Live/Pending |
LSLTTT Holdings Inc. 2024-03-08 |
 IGLOO 98439140 not registered Live/Pending |
HES TRADE LLC 2024-03-07 |
 IGLOO 98221198 not registered Live/Pending |
Hawk Enterprises 2, LLC 2023-10-12 |
 IGLOO 97775912 not registered Live/Pending |
Towers Watson Software Limited 2023-02-01 |
 IGLOO 97763410 not registered Live/Pending |
Eskimo Software 2023-01-21 |
 IGLOO 97200295 not registered Live/Pending |
Kai U.S.A., Ltd. 2022-01-03 |
 IGLOO 97049115 not registered Live/Pending |
Danke Co.,Ltd. 2021-09-28 |
 IGLOO 88978521 not registered Live/Pending |
IGLOO PRODUCTS CORP. 2019-10-22 |
 IGLOO 88878460 not registered Live/Pending |
Parker, Isaac 2020-04-20 |
 IGLOO 88663631 not registered Live/Pending |
IGLOO PRODUCTS CORP. 2019-10-22 |
 IGLOO 88605799 not registered Live/Pending |
INTERNATIONAL FOODSTUFFS CO LLC 2019-09-05 |
 IGLOO 88496100 not registered Live/Pending |
Just One LLC 2019-07-01 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.