| Primary Device ID | 04065655000924 |
| NIH Device Record Key | 1b3e89ad-8a0c-47e0-bb17-336323b8201f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ERBEFLO CleverCap® |
| Version Model Number | 20325-219 |
| Catalog Number | 20325-219 |
| 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 | false |
| 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 |
| 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 | |
| Phone | 1-770-955-4400 |
| technicalservice@erbe-usa.com | |
| Phone | 1-770-955-4400 |
| technicalservice@erbe-usa.com |
| 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 |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 04050147012912 [Previous] |
| GS1 | 04065655000917 [Primary] |
| GS1 | 04065655000924 [Package] Contains: 04065655000917 Package: Level 1 [10 Units] In Commercial Distribution |
| GS1 | 04065655000931 [Package] Package: Level 2 [5 Units] In Commercial Distribution |
| FEQ | Pump, Air, Non-Manual, For Endoscope |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-02 |
| Device Publish Date | 2023-09-22 |
| 04065655001327 | Hybrid OFP & EndoStat Tubing/ Cap Set for Olympus® Scope |
| 04065655001228 | Hybrid Tubing/Cap Set for Fujifilm® Scopes |
| 04065655001174 | Hybrid Tubing/Cap Set for Pentax® Scopes |
| 04065655001105 | Hybrid CO2 Tubing/Cap Set for Fujinon® Scopes |
| 04065655001013 | Hybrid CO2 Tubing/Cap Set for Fujifilm® Scopes |
| 04065655000924 | CO2 Olympus® Connector Tube |
| 04065655000894 | CO2 Connector Tube |
| 04065655000863 | Hybrid CO2 Tubing/Cap Set for Pentax® Scopes |
| 04065655000610 | Hybrid Tubing/Cap Set for Olympus® Scopes |
| 04065655000825 | Hybrid CO2 Tubing/Cap Set for Olympus® Scopes |
| 04065655000405 | Hybrid CO2 Tubing/Cap Set for Olympus® Scopes & UCR |
| 04065655000375 | Hybrid CO2 Tubing/Cap Set for Olympus® Scopes & CO2 Sources |