Pertrach

GUDID 10841470104327

ENGINEERED MEDICAL SYSTEMS INC

Cricothyrotomy kit, single-use
Primary Device ID10841470104327
NIH Device Record Key7cbe65d2-8fa9-4a8c-9169-33bc26191a65
Commercial Distribution StatusIn Commercial Distribution
Brand NamePertrach
Version Model Number301-D4555
Company DUNS154502934
Company NameENGINEERED MEDICAL SYSTEMS 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 Usetrue
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

Customer Support Contacts

Phone317-246-5500
Emailinfo@engmedsys.com

Device Dimensions

Lumen/Inner Diameter3.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100841470104320 [Primary]
GS110841470104327 [Package]
Contains: 00841470104320
Package: [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTOTube, Tracheostomy (W/Wo Connector)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-05-27

On-Brand Devices [Pertrach]

10841470104396301-D4550
10841470104389301-D4559
10841470104372301-D4558
10841470104365301-D4554
10841470104358301-D4552
10841470104341301-D4553
10841470104334301-D4556
10841470104327301-D4555
10841470104310301-D4557
10841470103122301-D4551

Trademark Results [Pertrach]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PERTRACH
PERTRACH
78269728 2865139 Live/Registered
Engineered Medical Systems, Inc.
2003-07-02
PERTRACH
PERTRACH
74162705 1694198 Dead/Cancelled
LUTHER MEDICAL PRODUCTS, INC.
1991-05-01

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