AMBU Co2 Detector-Pedi

GUDID 05707480133765

Carbon Dioxide Detector Pediatric

WESTMED, INC.

Exhaled-gas oesophageal intubation detector, adult
Primary Device ID05707480133765
NIH Device Record Key166c8908-6285-4ace-a164-6889cbdddbd4
Commercial Distribution StatusIn Commercial Distribution
Brand NameAMBU Co2 Detector-Pedi
Version Model Number000-172-713
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
GS105707480101061 [Primary]
GS105707480133765 [Package]
Contains: 05707480101061
Package: [12 Units]
In Commercial Distribution

FDA Product Code

CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-23
Device Publish Date2022-08-15

Devices Manufactured by WESTMED, INC.

20889483528614 - AMBU Hyperinflation System2026-03-13 Hyperinflation System, 1/2L Bag, 7' O2 and Manometer, 40 cm H2O Pop-Off Valve with Override
20889483528737 - AMBU Hyperinflation System2026-03-13 Hyperinflation System, 1/2L Bag, 7' O2 and Manometer, Neonatal Mask, 40 cm H2O Pop-Off Valve with Override
20889483528751 - AMBU Hyperinflation System2026-03-13 Hyperinflation System, 1/2L Bag, 7' O2 and Manometer, Infant Mask, 40 cm H2O Pop-Off Valve with Override
20889483528867 - AMBU Hyperinflation System2026-03-13 Hyperinflation System, 1L Bag, 7' O2 and Manometer, Pediatric Mask, 40 cm H2O Pop-Off Valve with Override
20889483528942 - AMBU Hyperinflation System2026-03-13 Hyperinflation System, 1L Bag, 7' O2 and Manometer, 40 cm H2O Pop-Off Valve with Override
20889483568795 - AMBU Hyperinflation System2026-03-13 Hyperinflation System, 3L Bag 7' O2 and Pressure Lines
20889483542801 - AMBU Hyperinflation System2026-03-13 Hyperinflation System, 2L Bag, 7' O2 and Pressure lines
20889483542849 - AMBU Hyperinflation System2026-03-13 Hyperinflation System, 1/2L Bag, 7' O2 and Manometer

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.