ABC - Duoflow Bi-lumen Breathing Circuit

GUDID 10841470106734

ENGINEERED MEDICAL SYSTEMS INC

Anaesthesia breathing circuit, single-use
Primary Device ID10841470106734
NIH Device Record Key0654ee34-1cb2-49fb-831a-933ac26c7f37
Commercial Distribution StatusIn Commercial Distribution
Brand NameABC - Duoflow Bi-lumen Breathing Circuit
Version Model NumberD072323M0X1A4
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
GS100841470106737 [Primary]
GS110841470106734 [Package]
Contains: 00841470106737
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 - Duoflow Bi-lumen Breathing Circuit]

10841470109506D120323M1X1A4
10841470108943D72M317M1X1A4
10841470108738D12M317M1X1A4
10841470106734D072323M0X1A4
10841470106284D072323M2X1E4

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.