| Primary Device ID | 15420045507401 |
| NIH Device Record Key | d7b5f038-95e3-4324-b562-c5094ef8b240 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fluent Fluid Management System |
| Version Model Number | FLT-112S |
| Catalog Number | FLT-112S |
| Company DUNS | 018925968 |
| Company Name | Hologic, Inc. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15420045507401 [Primary] |
| GS1 | 25420045507408 [Package] Package: BOX [1 Units] In Commercial Distribution |
| GS1 | 35420045507405 [Package] Package: BOX [1 Units] In Commercial Distribution |
| GS1 | 45420045507402 [Package] Package: CARTON [6 Units] In Commercial Distribution |
| HIG | INSUFFLATOR, HYSTEROSCOPIC |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[15420045507401]
Ethylene Oxide
[15420045507401]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-09-28 |
| Device Publish Date | 2018-08-28 |
| 15420045507401 | FLT-112S |
| 45420045507662 | The Fluent Fluid Management System is intended to provide liquid distension of the uterus during |
| 45420045505279 | The Fluent Fluid Management System is intended to provide liquid distension of the uterus during |