ERBEFLO® 20325-225
GUDID 04065655001396
Olympus® Scope Port Connector
Erbe Medical, LLC
Surgical irrigation tubing set, single-use| Primary Device ID | 04065655001396 |
| NIH Device Record Key | 2a1152c9-f1aa-4e49-9341-fba1c049d155 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ERBEFLO® |
| Version Model Number | 20325-225 |
| Catalog Number | 20325-225 |
| Company DUNS | 117862528 |
| Company Name | Erbe Medical, LLC |
| 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 | 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 | 1-770-955-4400 |
| technicalservice@erbe-usa.com | |
| Phone | 1-770-955-4400 |
| technicalservice@erbe-usa.com | |
| Phone | 1-770-955-4400 |
| technicalservice@erbe-usa.com | |
| Phone | 1-770-955-4400 |
| technicalservice@erbe-usa.com | |
| Phone | 1-770-955-4400 |
| technicalservice@erbe-usa.com | |
| Phone | 1-770-955-4400 |
| technicalservice@erbe-usa.com | |
| Phone | 1-770-955-4400 |
| technicalservice@erbe-usa.com | |
| Phone | 1-770-955-4400 |
| technicalservice@erbe-usa.com | |
| Phone | 1-770-955-4400 |
| technicalservice@erbe-usa.com | |
| Phone | 1-770-955-4400 |
| technicalservice@erbe-usa.com | |
| Phone | 1-770-955-4400 |
| technicalservice@erbe-usa.com | |
| Phone | 1-770-955-4400 |
| technicalservice@erbe-usa.com | |
| Phone | 1-770-955-4400 |
| technicalservice@erbe-usa.com | |
| Phone | 1-770-955-4400 |
| technicalservice@erbe-usa.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat and direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat and direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat and direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat and direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat and direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat and direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat and direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat and direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat and direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat and direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat and direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat and direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat and direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat and direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04050147021891 [Previous] |
| GS1 | 04065655001396 [Primary] |
| GS1 | 04065655001402 [Package] Package: Level 1 [10 Units] In Commercial Distribution |
| GS1 | 04065655001419 [Package] Contains: 04065655001402 Package: Level 2 [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K182444
FDA Product Code
| OCX | Endoscopic Irrigation/Suction System |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-19 |
| Device Publish Date | 2023-10-11 |
Devices Manufactured by Erbe Medical, LLC
| 04065655001396 - ERBEFLO® | 2023-10-19Olympus® Scope Port Connector |
| 04065655001396 - ERBEFLO® | 2023-10-19 Olympus® Scope Port Connector |
| 04065655000375 - ERBEFLO CleverCap® | 2023-10-02 Hybrid CO2 Tubing/Cap Set for Olympus® Scopes & CO2 Sources |
| 04065655000405 - ERBEFLO CleverCap® | 2023-10-02 Hybrid CO2 Tubing/Cap Set for Olympus® Scopes & UCR |
| 04065655000825 - ERBEFLO CleverCap® | 2023-10-02 Hybrid CO2 Tubing/Cap Set for Olympus® Scopes |
| 04065655000610 - ERBEFLO CleverCap® | 2023-10-02 Hybrid Tubing/Cap Set for Olympus® Scopes |
| 04065655000863 - ERBEFLO CleverCap® | 2023-10-02 Hybrid CO2 Tubing/Cap Set for Pentax® Scopes |
| 04065655000894 - ERBEFLO CleverCap® | 2023-10-02 CO2 Connector Tube |
| 04065655000924 - ERBEFLO CleverCap® | 2023-10-02 CO2 Olympus® Connector Tube |
Trademark Results [ERBEFLO]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ERBEFLO 85134635 3965675 Live/Registered |
ERBE USA, Inc. 2010-09-21 |
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