ABC - Pediatric Compact Breathing Circuit

GUDID 10841470108844

ENGINEERED MEDICAL SYSTEMS INC

Anaesthesia breathing circuit, single-use
Primary Device ID10841470108844
NIH Device Record Key654b719d-8e91-43fe-af8c-b2e6e2a9925b
Commercial Distribution StatusIn Commercial Distribution
Brand NameABC - Pediatric Compact Breathing Circuit
Version Model NumberPC12123M90000
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
GS100841470108847 [Primary]
GS110841470108844 [Package]
Contains: 00841470108847
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 - Pediatric Compact Breathing Circuit]

10841470108950PC12113M0X500
10841470108844PC12123M90000

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