| Primary Device ID | 05707480133765 |
| NIH Device Record Key | 166c8908-6285-4ace-a164-6889cbdddbd4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AMBU Co2 Detector-Pedi |
| Version Model Number | 000-172-713 |
| Company DUNS | 092673953 |
| Company Name | WESTMED, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05707480101061 [Primary] |
| GS1 | 05707480133765 [Package] Contains: 05707480101061 Package: [12 Units] In Commercial Distribution |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-08-23 |
| Device Publish Date | 2022-08-15 |
| 20889483528614 - AMBU Hyperinflation System | 2026-03-13 Hyperinflation System, 1/2L Bag, 7' O2 and Manometer, 40 cm H2O Pop-Off Valve with Override |
| 20889483528737 - AMBU Hyperinflation System | 2026-03-13 Hyperinflation System, 1/2L Bag, 7' O2 and Manometer, Neonatal Mask, 40 cm H2O Pop-Off Valve with Override |
| 20889483528751 - AMBU Hyperinflation System | 2026-03-13 Hyperinflation System, 1/2L Bag, 7' O2 and Manometer, Infant Mask, 40 cm H2O Pop-Off Valve with Override |
| 20889483528867 - AMBU Hyperinflation System | 2026-03-13 Hyperinflation System, 1L Bag, 7' O2 and Manometer, Pediatric Mask, 40 cm H2O Pop-Off Valve with Override |
| 20889483528942 - AMBU Hyperinflation System | 2026-03-13 Hyperinflation System, 1L Bag, 7' O2 and Manometer, 40 cm H2O Pop-Off Valve with Override |
| 20889483568795 - AMBU Hyperinflation System | 2026-03-13 Hyperinflation System, 3L Bag 7' O2 and Pressure Lines |
| 20889483542801 - AMBU Hyperinflation System | 2026-03-13 Hyperinflation System, 2L Bag, 7' O2 and Pressure lines |
| 20889483542849 - AMBU Hyperinflation System | 2026-03-13 Hyperinflation System, 1/2L Bag, 7' O2 and Manometer |