LC

GUDID 00744229100355

Nose Clip

PARI RESPIRATORY EQUIPMENT, INC.

Mechanical positive pressure airway secretion-clearing device
Primary Device ID00744229100355
NIH Device Record Keyf56e64a1-5d32-4af5-9c9c-5146372c724f
Commercial Distribution StatusIn Commercial Distribution
Brand NameLC
Version Model Number041F3500
Company DUNS804736098
Company NamePARI RESPIRATORY EQUIPMENT, 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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100744229100355 [Package]
Contains: 00744229410881
Package: carton [12 Units]
In Commercial Distribution
GS100744229410881 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BWFSpirometer, Therapeutic (Incentive)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-11-17

On-Brand Devices [LC]

00744229100355Nose Clip
00744229100331Filter Pad
00744229100560Mouthpiece, LC Neb, Standard

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