Aero-Pro HEPA Small Straight

GUDID 00841470109905

PULMODYNE INC

Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use

Primary Device ID	00841470109905
NIH Device Record Key	0ccb65b1-0eb6-413c-92eb-9838fe89835e
Commercial Distribution Status	In Commercial Distribution
Brand Name	Aero-Pro HEPA Small Straight
Version Model Number	20161
Company DUNS	030619483
Company Name	PULMODYNE INC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841470109905 [Primary]
GS1	10841470109902 [Package] Package: [25 Units] In Commercial Distribution

FDA Product Code

CAH	Filter, Bacterial, Breathing-Circuit

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-04-04
Device Publish Date	2022-03-25

On-Brand Devices [Aero-Pro HEPA Small Straight]

00841470109905	20161
10841470109896	20162