LCD

GUDID 00744229220213

LC Disp. Neb Set, Adult Mask

PARI RESPIRATORY EQUIPMENT, INC.

Nebulizing system delivery set, reusable
Primary Device ID00744229220213
NIH Device Record Key226b3e9d-e140-43b2-8ae8-33816e15603b
Commercial Distribution StatusIn Commercial Distribution
Brand NameLCD
Version Model Number022H72
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100744229220206 [Primary]
GS100744229220213 [Package]
Contains: 00744229220206
Package: carton [50 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAFNebulizer (Direct Patient Interface)

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 Date2016-10-06

On-Brand Devices [LCD]

00744229220237LC Disp. Neb Set, Ped. Mask
00744229220213LC Disp. Neb Set, Adult Mask
00744229220190LC Disp. Neb Set

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