| Primary Device ID | 00612649151403 |
| NIH Device Record Key | cd0e5b00-28a6-405b-9de3-ec0d52a4426a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PEDIATRIC UNIVERSAL F2® |
| Version Model Number | F02 |
| Catalog Number | F02 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00612649151403 [Package] Contains: 00612649202693 Package: [30 Units] In Commercial Distribution |
| GS1 | 00612649202693 [Primary] |
| CAI | Circuit, breathing (w connector, adaptor, y piece) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-02-17 |
| Device Publish Date | 2023-02-09 |
| 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 |