| Primary Device ID | 00612649188416 |
| NIH Device Record Key | 0f0891d4-5117-4723-b4ea-d4a6ba550d40 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CUSTOM ACCESSORY KIT |
| Version Model Number | 370L |
| Catalog Number | 370L |
| Company DUNS | 009299017 |
| Company Name | King Systems Corporation |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(410)768-6464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +1(410)768-6464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +1(410)768-6464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +1(410)768-6464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +1(410)768-6464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +1(410)768-6464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +1(410)768-6464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +1(410)768-6464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +1(410)768-6464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +1(410)768-6464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +1(410)768-6464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +1(410)768-6464 |
| Purchase_orders@ambuUSA.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00612649162072 [Package] Package: [20 Units] In Commercial Distribution |
| GS1 | 00612649188416 [Primary] |
| CAI | Circuit, breathing (w connector, adaptor, y piece) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2026-01-30 |
| Device Publish Date | 2022-12-08 |
| 00612649214559 - UNIVERSAL F® FLEX2® | 2026-02-02 UNIVERSAL F FLEX2 CIRCUIT |
| 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 |