Adult Bacterial/Viral Filter with C02 Port MC-555X

GUDID 10858409005365

Medicomp

Tube/mask breathing circuit connector, single-use, non-sterile
Primary Device ID10858409005365
NIH Device Record Key31afcf0a-00b7-4860-b15c-768568693ae1
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdult Bacterial/Viral Filter with C02 Port
Version Model NumberMC-555X
Catalog NumberMC-555X
Company DUNS154454730
Company NameMedicomp
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100858409005368 [Primary]
GS110858409005365 [Package]
Contains: 00858409005368
Package: case [50 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAHFilter, Bacterial, Breathing-Circuit

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-01-23
Device Publish Date2017-09-11

Devices Manufactured by Medicomp

10858409005631 - Pediatric HME2020-08-14
10858409005624 - Large Manual Percussor Cup; 89mm2020-04-30 Large Manual Percussor Cup; 89mm
10858409005280 - C02 Sampling Adapter2019-11-27
10858409005372 - Washington Tee2019-11-27
10858409005389 - C02 Sampling Adapter with Cap2019-11-27
00858409005009 - Adult Bacterial/Viral Filter2019-01-23
10858409005013 - Infant Bacterial/Viral Filter2019-01-23
00858409005023 - Nebulizer Bacteria Filter2019-01-23

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