ULTI-MIST™ HME/F ICUAND FLEX CONNECTOR AN-01217
GUDID 00612649141978
ULTIMIST HME/F&FLEX CONNECTOR
King Systems Corporation
Heat/moisture exchanger/microbial filter, non-sterile| Primary Device ID | 00612649141978 |
| NIH Device Record Key | ae423951-2b9c-4745-9d59-606b4b0e5579 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ULTI-MIST™ HME/F ICUAND FLEX CONNECTOR |
| Version Model Number | AN-01217 |
| Catalog Number | AN-01217 |
| Company DUNS | 009299017 |
| Company Name | King Systems Corporation |
| 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 |
Customer Support Contacts
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00612649141978 [Package] Contains: 00612649199955 Package: [50 Units] In Commercial Distribution |
| GS1 | 00612649199955 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K983817
FDA Product Code
| CAH | Filter, bacterial, breathing-circuit |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-12-14 |
| Device Publish Date | 2016-09-22 |
Devices Manufactured by King Systems Corporation
| 00612649100494 - CORRUGATED TUBING | 2026-01-30 TUBING,100' SEGMENTED COIL |
| 00612649185224 - WASHINGTON CONNECTOR | 2026-01-30 CUSTOM ACCESSORY |
| 00612649106779 - 100 FT 22MM ULTRA FLEX® TUBING | 2026-01-30 TUBING 100 ULTRAFLEX COIL |
| 00612649121758 - 100 FT., 6" 22MM SEGMENTED | 2026-01-30 TUBING 100 SEGMENTED COIL |
| 00612649149103 - RE'SPOSABLE® F2® | 2026-01-30 RESPOSABLE F2 PLASTIC MANIFOLD |
| 00612649154114 - 18" REUSABLE TUBING | 2026-01-30 TUBING,18"REUSEABLE CREAM |
| 00612649190242 - BREATHING BAG | 2026-01-30 BREATHING BAG,3L,NEOPRENE |
| 00612649190181 - BREATHING BAG | 2026-01-30 BREATHING BAG,1/2L,NEOPRENE |
Trademark Results [ULTI-MIST]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ULTI-MIST 75642619 2519054 Live/Registered |
King Systems Corporation 1999-02-18 |
© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.