| Primary Device ID | 00612649215303 |
| NIH Device Record Key | 7f8fe4e6-6c4c-4834-8d72-33c8c139c7ec |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | UNIVERSAL FLEX2® |
| Version Model Number | KNDF475-6121Z |
| Catalog Number | KNDF475-6121Z |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| 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 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00612649215303 [Package] Contains: 00612649215310 Package: [50 Units] In Commercial Distribution |
| GS1 | 00612649215310 [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 | 2022-10-24 |
| Device Publish Date | 2021-05-28 |
| 00612649213842 | UNIVERSAL FLEX2 CIRCUIT |
| 00612649213828 | UNIVERSAL FLEX2 CIRCUIT |
| 00612649215365 | UNIVERSAL FLEX2 CIRCUIT |
| 00612649215341 | UNIVERSAL FLEX2 CIRCUIT |
| 00612649215280 | UNIVERSAL FLEX2 CIRCUIT |
| 00612649215266 | UNIVERSAL FLEX2 CIRCUIT |
| 00612649215303 | UNIVERSAL FLEX2 CIRCUIT |
| 00612649163789 | UNIVERSAL FLEX2 CIRCUIT |
| 00612649217086 | UNIVERSAL FLEX2 CIRCUIT |
| 00612649217062 | UNIVERSAL FLEX2 CIRCUIT |
| 00612649217048 | UNIVERSAL FLEX2 CIRCUIT |
| 00612649217024 | UNIVERSAL FLEX2 CIRCUIT |
| 00612649217000 | UNIVERSAL FLEX2 CIRCUIT |
| 00612649216942 | UNIVERSAL FLEX2 CIRCUIT |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() UNIVERSAL FLEX2 76588618 3088083 Live/Registered |
King Systems Corporation 2004-04-26 |