BAROguard PRGNX-7007-001

GUDID 10850005470318

BAROguard Shipper Inner Box: Contains BAROguard Shipper (00850005470311)

PARAGONIX TECHNOLOGIES INC

General-purpose donor-organ preservation/transport system
Primary Device ID10850005470318
NIH Device Record Keyb4f5cefa-4c15-4359-9832-9251be13afc6
Commercial Distribution StatusIn Commercial Distribution
Brand NameBAROguard
Version Model Number112
Catalog NumberPRGNX-7007-001
Company DUNS961780660
Company NamePARAGONIX TECHNOLOGIES INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
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
GS110850005470318 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KDNSystem, Perfusion, Kidney

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-17
Device Publish Date2023-11-09

On-Brand Devices [BAROguard]

20850005470315BAROguard Shipper Outer Box Contains BAROguard Shipper Inner Box (10850005470318)
10850005470318BAROguard Shipper Inner Box: Contains BAROguard Shipper (00850005470311)
10850005470233BAROguard Sterile Components Outer Box Contains: BAROguard Sterile Components Inner Box (0085000
10850005470226BAROguard SherpaCool Outer Box Contains: BAROguard SherpaCool Inner Box (00850005470229)
00850005470311BAROguard Shipper
00850005470236BAROguard Sterile Components - Inner Box Contains: Organ Container Bag Pouch (00850005470205) Tr
00850005470229BAROguard SherpaCool Inner Box
00850005470212BAROguard Sterile Components - Trachea Connector Pouch
00850005470205BAROguard Sterile Components - Organ Container Bag Pouch
00850005470199BAROguard Sterile Components - Zip Tie Gun Pouch
00850005470069BAROguard SherpaCool

Trademark Results [BAROguard]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BAROGUARD
BAROGUARD
97597074 not registered Live/Pending
Paragonix Technologies, Inc.
2022-09-19
BAROGUARD
BAROGUARD
88702881 not registered Live/Pending
Paragonix Technologies, Inc.
2019-11-22

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