ABC - Compact Breathing Circuit

GUDID 10841470109452

ENGINEERED MEDICAL SYSTEMS INC

Anaesthesia breathing circuit, single-use
Primary Device ID10841470109452
NIH Device Record Key8149f981-fd02-45fa-ad42-f6a37e498cae
Commercial Distribution StatusIn Commercial Distribution
Brand NameABC - Compact Breathing Circuit
Version Model NumberC120323M0X1C5
Company DUNS154502934
Company NameENGINEERED MEDICAL SYSTEMS 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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100841470109455 [Primary]
GS110841470109452 [Package]
Contains: 00841470109455
Package: [10 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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-21
Device Publish Date2025-04-11

On-Brand Devices [ABC - Compact Breathing Circuit]

10841470109490C120323M1X1E5
10841470109483C072323M1X1A4
10841470109452C120323M0X1C5
10841470106581C120323M0X1E5
10841470106574C120323M0X1A4

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