| Primary Device ID | 00852588007083 |
| NIH Device Record Key | 8b9ad45d-347a-4463-8dde-ce4cb68fdcf5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | INSUFLOW SYNERGY PORT |
| Version Model Number | 1991 |
| Catalog Number | 1991 |
| Company DUNS | 848693730 |
| Company Name | LEXION 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00852588007083 [Primary] |
| HIF | Insufflator, Laparoscopic |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00852588007083]
Ethylene Oxide
[00852588007083]
Ethylene Oxide
[00852588007083]
Ethylene Oxide
[00852588007083]
Ethylene Oxide
[00852588007083]
Ethylene Oxide
[00852588007083]
Ethylene Oxide
[00852588007083]
Ethylene Oxide
[00852588007083]
Ethylene Oxide
[00852588007083]
Ethylene Oxide
[00852588007083]
Ethylene Oxide
[00852588007083]
Ethylene Oxide
[00852588007083]
Ethylene Oxide
[00852588007083]
Ethylene Oxide
[00852588007083]
Ethylene Oxide
[00852588007083]
Ethylene Oxide
[00852588007083]
Ethylene Oxide
[00852588007083]
Ethylene Oxide
[00852588007083]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-01-09 |
| Device Publish Date | 2017-02-15 |
| 00852588007243 - Standard filtered tube set | 2022-06-10 Standard insufflation tube set, filtered, single use |
| 00852588007229 - AP50/30 | 2020-11-10 High Flow Insufflator |
| 00852588007069 - VERYCLEAR | 2020-01-09 SINGLE LUMEN GAS EVACUATION PORT |
| 00852588007083 - INSUFLOW SYNERGY PORT | 2020-01-095mm GAS CONDITIONING PORT |
| 00852588007083 - INSUFLOW SYNERGY PORT | 2020-01-09 5mm GAS CONDITIONING PORT |
| 00852588007090 - INSUFLOW SYNERGY XL PORT | 2020-01-09 8mm GAS CONDITIONING PORT |
| 00852588007106 - INSUFLOW SYNERGY XL PORT | 2020-01-09 10mm GAS CONDITIONING PORT |
| 00852588007113 - INSUFLOW SYNERGY XL PORT | 2020-01-09 12mm GAS CONDITIONING PORT |
| 00852588007120 - INSUFLOW SYNERGY XL PORT | 2020-01-09 8mm X 130mm GAS CONDITIONING PORT |