Hyperinflation AMBU

GUDID 05707480137718

Disposable Hyperinflation System, 1L Bag, 7' O2 and Manometer Infant Mask, 40 cm H2O Pop-off Valve

WESTMED, INC.

Ventilator breathing circuit, single-use
Primary Device ID05707480137718
NIH Device Record Key61c8cf74-f238-4dfc-82c4-975a746cea0c
Commercial Distribution StatusIn Commercial Distribution
Brand NameHyperinflation AMBU
Version Model Number900 000 623
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 Datefalse
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
GS105707480137701 [Primary]
GS105707480137718 [Package]
Contains: 05707480137701
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 Number2
Public Version Date2019-11-27
Device Publish Date2019-07-24

On-Brand Devices [Hyperinflation AMBU]

05707480137732Disposable Hyperinflation System, 1L bag, 7' O2 and Manometer, pediatric mask, 40 cm H2O Pop-off Valve
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 Valve
05707480137657Disposable Hyperinflation System, 1L bag, 7' O2 and Manometer, pediatric mask, 40 cm H2O Pop-off Valve
05707480137596Disposable Hyperinflation System, 1/2 Bag, 7' O2 and Manometer, Neonatal Mask, 40 cm H2O pop-off valve
05707480137534Disposable Hyperinflation System, 1/2 Bag 7' O2 and Manometer 40 cm H2O Pop-Off Valve

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