Primary Device ID | 05707480137770 |
NIH Device Record Key | e5ebad6f-f170-40fc-801d-3dea8af09a3b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Hyperinflation AMBU |
Version Model Number | 900 000 626 |
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 | false |
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 | 05707480137763 [Primary] |
GS1 | 05707480137770 [Package] Contains: 05707480137763 Package: [12 Units] In Commercial Distribution |
BZR | Mixer, Breathing Gases, Anesthesia Inhalation |
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 | 2019-07-24 |
05707480137732 | Disposable Hyperinflation System, 1L bag, 7' O2 and Manometer, pediatric mask, 40 cm H2O Pop-off |
05707480137619 | Disposable Hyperinflation System, 7' O2 and Manometer, 40 CM POP off Valve, Infant Mask |
05707480137770 | Disposable Hyperinflation System, 3L bag, 7' O2 and Pressure Lines, Adult mask |
05707480137756 | Disposable Hyperinflation System, 2L bag, 7' O2 and pressure lines, adult mask |
05707480137718 | Disposable Hyperinflation System, 1L Bag, 7' O2 and Manometer Infant Mask, 40 cm H2O Pop-off Val |
05707480137657 | Disposable Hyperinflation System, 1L bag, 7' O2 and Manometer, pediatric mask, 40 cm H2O Pop-off |
05707480137596 | Disposable Hyperinflation System, 1/2 Bag, 7' O2 and Manometer, Neonatal Mask, 40 cm H2O pop-off |
05707480137534 | Disposable Hyperinflation System, 1/2 Bag 7' O2 and Manometer 40 cm H2O Pop-Off Valve |