HMEF

GUDID 10841470105454

PULMODYNE INC

Heat/moisture exchanger/microbial medical gas filter
Primary Device ID10841470105454
NIH Device Record Keycebb77c7-d59f-475a-b537-a3280f21cf0a
Commercial Distribution StatusIn Commercial Distribution
Brand NameHMEF
Version Model Number1331302
Company DUNS030619483
Company NamePULMODYNE INC
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100841470105457 [Primary]
GS110841470105454 [Package]
Contains: 00841470105457
Package: [60 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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-09
Device Publish Date2024-07-01

On-Brand Devices [HMEF]

108414701054851333002
108414701054781341902
108414701054611332402
108414701054541331302

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.