Hyperinflation AMBU

GUDID 05707480137619

Disposable Hyperinflation System, 7' O2 and Manometer, 40 CM POP off Valve, Infant Mask

WESTMED, INC.

Ventilator breathing circuit, single-use
Primary Device ID05707480137619
NIH Device Record Keycd9a1c84-cce9-4e8d-ba5d-0122f8649696
Commercial Distribution StatusIn Commercial Distribution
Brand NameHyperinflation AMBU
Version Model Number900 000 618
Company DUNS092673953
Company NameWESTMED, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105707480137602 [Primary]
GS105707480137619 [Package]
Contains: 05707480137602
Package: [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BZRMixer, Breathing Gases, Anesthesia Inhalation

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-11-27
Device Publish Date2019-08-07

On-Brand Devices [Hyperinflation AMBU]

05707480137732Disposable Hyperinflation System, 1L bag, 7' O2 and Manometer, pediatric mask, 40 cm H2O Pop-off
05707480137619Disposable Hyperinflation System, 7' O2 and Manometer, 40 CM POP off Valve, Infant Mask
05707480137770Disposable Hyperinflation System, 3L bag, 7' O2 and Pressure Lines, Adult mask
05707480137756Disposable Hyperinflation System, 2L bag, 7' O2 and pressure lines, adult mask
05707480137718Disposable Hyperinflation System, 1L Bag, 7' O2 and Manometer Infant Mask, 40 cm H2O Pop-off Val
05707480137657Disposable Hyperinflation System, 1L bag, 7' O2 and Manometer, pediatric mask, 40 cm H2O Pop-off
05707480137596Disposable Hyperinflation System, 1/2 Bag, 7' O2 and Manometer, Neonatal Mask, 40 cm H2O pop-off
05707480137534Disposable Hyperinflation System, 1/2 Bag 7' O2 and Manometer 40 cm H2O Pop-Off Valve

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.