Aero-Sat

GUDID 10841470109803

PULMODYNE INC

Heat/moisture exchanger, single-use
Primary Device ID10841470109803
NIH Device Record Key8a926478-fadd-448b-8bb6-08a2fc50934a
Commercial Distribution StatusIn Commercial Distribution
Brand NameAero-Sat
Version Model Number000102
Company DUNS030619483
Company NamePULMODYNE 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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100841470109806 [Primary]
GS110841470109803 [Package]
Contains: 00841470109806
Package: [25 Units]
In Commercial Distribution
GS120841470109800 [Package]
Contains: 00841470109806
Package: [500 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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-04
Device Publish Date2020-07-27

On-Brand Devices [Aero-Sat]

10841470110212000602
10841470110434102302
10841470110267000702
10841470109803000102

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