Control-Cric

GUDID 10841470109063

PULMODYNE INC

Cricothyrotomy kit, single-use
Primary Device ID10841470109063
NIH Device Record Key58ca4a66-402d-4f94-bf11-ffc9aab34ee2
Commercial Distribution StatusIn Commercial Distribution
Brand NameControl-Cric
Version Model Number313-4567
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100841470109066 [Primary]
GS110841470109063 [Package]
Contains: 00841470109066
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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-08
Device Publish Date2021-09-30

Devices Manufactured by PULMODYNE INC

10841470105454 - HMEF2024-07-09
10841470105461 - HMEF2024-07-09
10841470105478 - HMEF2024-07-09
10841470105485 - HMEF2024-07-09
10841470100718 - VT Select2023-04-18
10841470100749 - VT Select2023-04-18
10841470100770 - VT Select2023-04-18
10841470100794 - VT Select2023-04-18

Trademark Results [Control-Cric]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CONTROL-CRIC
CONTROL-CRIC
90554889 not registered Live/Pending
Engineered Medical Systems, Inc.
2021-03-02

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