| Primary Device ID | 00612649213897 |
| NIH Device Record Key | c7131b69-ec6a-4690-818b-71d6047eb9ed |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PEDIATRIC ULTRA FLEX® |
| Version Model Number | 21816P-13621 |
| Catalog Number | 21816P-13621 |
| 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 | false |
| 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 | |
| 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 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00612649213897 [Package] Contains: 00612649213903 Package: [20 Units] In Commercial Distribution |
| GS1 | 00612649213903 [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 | 2019-11-27 |
| Device Publish Date | 2019-05-28 |
| 00612649213897 | PEDIATRIC ULTRAFLEX CIRCUIT |
| 00612649215105 | PEDIATRIC ULTRAFLEX CIRCUIT |
| 00612649181400 | PEDIATRIC ULTRAFLEX CIRCUIT |
| 00612649146539 | PEDIATRIC ULTRAFLEX CIRCUIT |
| 00612649153926 | PEDIATRIC ULTRAFLEX CIRCUIT |
| 00612649165707 | PEDIATRIC ULTRAFLEX CIRCUIT |
| 00612649105758 | PEDIATRIC ULTRAFLEX CIRCUIT |
| 00612649105734 | PEDIATRIC ULTRAFLEX CIRCUIT |
| 00612649105680 | PEDIATRIC ULTRAFLEX CIRCUIT |
| 00612649149066 | PEDIATRIC ULTRAFLEX CIRCUIT |
| 00612649165912 | PEDIATRIC ULTRAFLEX CIRCUIT |
| 00612649157979 | PEDIATRIC ULTRAFLEX CIRCUIT |
| 00612649215549 | PEDIATRIC ULTRAFLEX CIRCUIT |
| 00612649215525 | PEDIATRIC ULTRAFLEX CIRCUIT |
| 00612649216201 | PEDIATRIC ULTRAFLEX CIRCUIT |
| 00612649216225 | PEDIATRIC ULTRAFLEX CIRCUIT |
| 00612649151250 | PEDIATRIC ULTRAFLEX CIRCUIT |
| 00612649217215 | BREATHING CIRCUIT |