Neonatal HME MC-790

GUDID 10858409005198

Medicomp

Heat/moisture exchanger, single-use
Primary Device ID10858409005198
NIH Device Record Keye02b3e6a-8b5c-4d3c-ae1d-56acdc42e5c9
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeonatal HME
Version Model NumberMC-790
Catalog NumberMC-790
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
GS100858409005191 [Primary]
GS110858409005198 [Package]
Contains: 00858409005191
Package: case [50 Units]
In Commercial Distribution

FDA Product Code

BYDCondenser, Heat And Moisture (Artificial Nose)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
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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