UNIVERSAL F® FLEX2® F22001
GUDID 00612649216386
UNIVERSAL F FLEX2 CIRCUIT & Pack Kit
King Systems Corporation
Anaesthesia breathing circuit, single-use| Primary Device ID | 00612649216386 |
| NIH Device Record Key | e24dbc89-0943-4196-8ecf-ce972c9d028a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | UNIVERSAL F® FLEX2® |
| Version Model Number | F22001 |
| Catalog Number | F22001 |
| 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 | true |
| 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 |
Customer Support Contacts
| Phone | +14107686464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +14107686464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +14107686464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +14107686464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +14107686464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +14107686464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +14107686464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +14107686464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +14107686464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +14107686464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +14107686464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +14107686464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +14107686464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +14107686464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +14107686464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +14107686464 |
| Purchase_orders@ambuUSA.com |
Device Dimensions
| Length | 350 Millimeter |
| Outer Diameter | 5 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 2 Millimeter |
| Length | 350 Millimeter |
| Outer Diameter | 5 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 2 Millimeter |
| Length | 350 Millimeter |
| Outer Diameter | 5 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 2 Millimeter |
| Length | 350 Millimeter |
| Outer Diameter | 5 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 2 Millimeter |
| Length | 350 Millimeter |
| Outer Diameter | 5 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 2 Millimeter |
| Length | 350 Millimeter |
| Outer Diameter | 5 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 2 Millimeter |
| Length | 350 Millimeter |
| Outer Diameter | 5 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 2 Millimeter |
| Length | 350 Millimeter |
| Outer Diameter | 5 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 2 Millimeter |
| Length | 350 Millimeter |
| Outer Diameter | 5 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 2 Millimeter |
| Length | 350 Millimeter |
| Outer Diameter | 5 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 2 Millimeter |
| Length | 350 Millimeter |
| Outer Diameter | 5 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 2 Millimeter |
| Length | 350 Millimeter |
| Outer Diameter | 5 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 2 Millimeter |
| Length | 350 Millimeter |
| Outer Diameter | 5 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 2 Millimeter |
| Length | 350 Millimeter |
| Outer Diameter | 5 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 2 Millimeter |
| Length | 350 Millimeter |
| Outer Diameter | 5 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 2 Millimeter |
| Length | 350 Millimeter |
| Outer Diameter | 5 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 2 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00612649216386 [Package] Contains: 00612649216393 Package: [40 Units] In Commercial Distribution |
| GS1 | 00612649216393 [Primary] |
FDA Product Code
| CAI | Circuit, breathing (w connector, adaptor, y piece) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-05-26 |
| Device Publish Date | 2023-05-18 |
On-Brand Devices [UNIVERSAL F® FLEX2®]
| 00612649215167 | UNIVERSAL F FLEX2 CIRCUIT |
| 00612649215488 | UNIVERSAL F FLEX2 CIRCUIT |
| 00612649215464 | UNIVERSAL F FLEX2 CIRCUIT |
| 00612649215914 | UNIVERSAL FLEX2 CIRCUIT |
| 00612649215877 | UNIVERSAL F FLEX2 CIRCUIT |
| 00612649216447 | Universal F Flex Breathing Circuit |
| 00612649216423 | UNIVERSAL F FLEX2 CIRCUIT |
| 00612649216409 | UNIVERSAL F FLEX2 CIRCUIT |
| 00612649216386 | UNIVERSAL F FLEX2 CIRCUIT & Pack Kit |
Trademark Results [UNIVERSAL F]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 UNIVERSAL F 74475379 1884793 Live/Registered |
KING SYSTEMS CORPORATION 1994-01-03 |
 UNIVERSAL F 74323503 not registered Dead/Abandoned |
King Systems- Division of Burco Molding, Inc. 1992-10-19 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.