Trek S

GUDID 00744229470052

PARI Trek S Combo Pack

PARI RESPIRATORY EQUIPMENT, INC.

Nebulizing system delivery set, reusable Nebulizing system delivery set, reusable
Primary Device ID00744229470052
NIH Device Record Keyb23223dd-25b6-46a5-bc9e-fb1918cf7d72
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrek S
Version Model Number047F35-LCS
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 Batchfalse
Serial Numbertrue
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
GS100744229470052 [Primary]
GS100744229470168 [Package]
Package: carton [6 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 Date2016-09-23

On-Brand Devices [Trek S]

00744229470151PARI Trek S Replacement
00744229470175PARI Trek S with DC Adapter, custom label
00744229470212Adapter, multi-voltage, Trek S
00744229470229Battery, Replacement, Trek S
00744229470182PARI Trek S with DC Adapter
00744229470052PARI Trek S Combo Pack
00744229470236Port. Power Kit, TREK S
0074422947020512V DC Adapter, PARI Trek

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