ABC - Uniflow Breathing Circuit

GUDID 10841470107656

ENGINEERED MEDICAL SYSTEMS INC

Anaesthesia breathing circuit, single-use
Primary Device ID10841470107656
NIH Device Record Keyf8a38ab0-811e-4653-9fad-46638b21b0e6
Commercial Distribution StatusIn Commercial Distribution
Brand NameABC - Uniflow Breathing Circuit
Version Model NumberU096323M0X1A4
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
GS100841470107659 [Primary]
GS110841470107656 [Package]
Contains: 00841470107659
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 - Uniflow Breathing Circuit]

10841470109537U072323M0X1E5
10841470109520U072323M0X100
10841470107656U096323M0X1A4
10841470107113U072323M0X1A4
10841470106260U060323M1X1E4

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