Pertrach

GUDID 10841470100077

PULMODYNE INC

Cricothyrotomy kit, single-use
Primary Device ID10841470100077
NIH Device Record Key82807470-6c89-4fef-b8df-662f31a3f44f
Commercial Distribution StatusIn Commercial Distribution
Brand NamePertrach
Version Model Number313-D4555
Company DUNS030619483
Company NamePULMODYNE 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 Datetrue
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@pulmodyne.com

Device Dimensions

Lumen/Inner Diameter3.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100841470100070 [Primary]
GS110841470100077 [Package]
Contains: 00841470100070
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 Date2015-11-20

On-Brand Devices [Pertrach]

10841470100107313-D4559
10841470100091313-D4557
10841470100084313-D4556
10841470100077313-D4555
10841470100060313-D4554
10841470100053313-D4553
10841470100046313-D4552
10841470100039313-D4551
10841470100022313-D4550
10841470100015313-D4558

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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