Adult circuit, 120" Expandable Tubing

GUDID 10709078006149

WESTMED, INC.

Anaesthesia breathing circuit, single-use
Primary Device ID10709078006149
NIH Device Record Keya3a2a521-f866-4d74-8029-fdbefd0cbf10
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdult circuit, 120" Expandable Tubing
Version Model Number9632
Company DUNS092673953
Company NameWESTMED, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100709078006142 [Primary]
GS110709078006149 [Package]
Contains: 00709078006142
Package: [20 Units]
In Commercial Distribution

FDA Product Code

OFPAnesthesia Breathing Circuit Kit (Adult & Pediatric)

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 Date2018-09-25

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.